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ACTIVE PHARMA INGREDIENTS

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JDMF

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NDC API

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Chemistry

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Also known as: Dl-amphetamine sulfate, Amphetamine sulphate, Phenaminum, 60-13-9, Amphamine sulfate, Amphetamini sulfas
Molecular Formula
C18H28N2O4S
Molecular Weight
368.5  g/mol
InChI Key
PYHRZPFZZDCOPH-UHFFFAOYSA-N
FDA UNII
6DPV8NK46S

Amphetamine
Amphetamine Sulfate is the sulfate salt form of amphetamine, a synthetic substance related to natural sympathomimetic amines. Amphetamine appears to exert its central nervous system (CNS) and peripheral effects indirectly by inducing the release of biogenic amines from their storage sites in nerve terminals. This agent is a commonly abused psychostimulant drug, which may be snorted, taken orally, smoked, or injected. Amphetamine induces psychologic dependence which is manifested by elevated mood, increased wakefulness, concentration, physical performance and a feeling of well-being. With sustained use, the effects of tachycardia and enhanced alertness diminish while psychotoxic effects such as hallucinations and delusions may occur. (NCI04)
1 2D Structure

Amphetamine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-phenylpropan-2-amine;sulfuric acid
2.1.2 InChI
InChI=1S/2C9H13N.H2O4S/c2*1-8(10)7-9-5-3-2-4-6-9;1-5(2,3)4/h2*2-6,8H,7,10H2,1H3;(H2,1,2,3,4)
2.1.3 InChI Key
PYHRZPFZZDCOPH-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(CC1=CC=CC=C1)N.CC(CC1=CC=CC=C1)N.OS(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
6DPV8NK46S
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Dl-amphetamine Sulfate

2. Amphetamine Sulphate

3. Phenaminum

4. 60-13-9

5. Amphamine Sulfate

6. Amphetamini Sulfas

7. Dl-phenamine Sulfate

8. Dl-amphetamine Sulphate

9. Amphetaminium Sulfuricum

10. Desoxynorephedrine Sulfate

11. (+-)-amphetamine Sulfate

12. Dl-amphetamine Hydrogen Sulfate

13. (+-)-phenisopropylamine Sulfate

14. Amfetamine Sulfate

15. Amphetamine Sulfate [usp]

16. Dl-1-phenyl-2-aminopropane Sulfate

17. (+-)-2-amino-1-phenylpropane Sulfate

18. (+-)-alpha-methylphenethylamine Sulfate (2:1)

19. 6dpv8nk46s

20. 1-phenylpropan-2-amine Sulfate (2:1)

21. Amphetamine Sulfate (usp)

22. Fenopromin Sulfate

23. Penamine (van)

24. Ccris 3644

25. 1-phenyl-2-aminopropane Sulfate

26. Cerm 1767

27. Razemisches Phenylaminopropansulfat

28. Dl-alpha-methylphenethylamine Sulfate

29. Einecs 200-457-8

30. Unii-6dpv8nk46s

31. Nsc 170999

32. Dl-amphetamine Sulfate Salt

33. Benzadrine

34. Alpha-methylphenethylamine Sulfate, (+-)-

35. Benzedrine (tn)

36. Evekeo (tn)

37. Evekeo Odt

38. Rac-amphetamine Sulphate

39. D-amphetamine Sulfate Salt

40. Schembl41204

41. Amphetamine Sulfate [mi]

42. Dtxsid4020082

43. Phenethylamine, Alpha-methyl-, Sulfate (2:1), (+-)-

44. Chebi:51063

45. Amfetamine Sulfate [mart.]

46. Amphetamine Sulfate [vandf]

47. Amfetamine Sulfate [who-dd]

48. Bis{1-phenylpropan-2-amine} Sulfate

49. Amfetamine Sulfate [ep Impurity]

50. Amfetamine Sulfate [ep Monograph]

51. Amphetamine Sulfate [orange Book]

52. .beta.-phenylisopyropylaminesulfate

53. Benzeneethanamine, Alpha-methyl-, Sulfate

54. Amphetamine Sulfate [usp Monograph]

55. Amfetamine Sulfate [incb:green List]

56. Delcobese Component Amphetamine Sulfate

57. D02074

58. (+/-)-2-amino-1-phenylpropane Sulfate

59. (+/-)-2-amino-1-phenylpropane Sulphate

60. Amphetamine Sulfate Component Of Delcobese

61. Q21270844

62. (+/-)-.alpha.-methylphenethylamine Sulfate (2:1)

63. (+/-)-.alpha.-methylphenethylamine Sulphate (2:1)

64. Benzeneethanamine, .alpha.-methyl-, Sulfate (2:1), (+/-)-

65. Benzeneethanamine, .alpha.-methyl-, Sulphate (2:1), (+/-)-

66. Dl-amphetamine Sulfate Salt Solution, Drug Standard, 1.0 Mg/ml In Methanol

67. 2-(tetrahydro-furan-2-yl)-n-(3-trifluoromethyl-phenyl)-succinamicacid

68. 156-31-0

2.3.2 Other Synonyms

1. Amfetamine

2. Mydrial

3. Desoxynorephedrine

4. L Amphetamine

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 368.5 g/mol
Molecular Formula C18H28N2O4S
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count6
Rotatable Bond Count4
Exact Mass368.17697855 g/mol
Monoisotopic Mass368.17697855 g/mol
Topological Polar Surface Area135 Ų
Heavy Atom Count25
Formal Charge0
Complexity166
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count2
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3

Listed Suppliers

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01

Veranova

U.S.A
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Antibody Engineering
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  • WHO-GMP

Virtual BoothVeranova: A CDMO that manages complexity with confidence.

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Amphetamine

About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...

Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle. Macfarlan Smith Limited is trading as Veranova in the United Kingdom.
Veranova

02

AXYNTIS Group

France
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AXYNTIS Group

France
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Amphetamine Sulfate

About the Company : Axyntis Group, founded in 2007, is France’s leading independent multi-site player in fine chemicals with a €90 million annual turnover. Axyntis has become a key producer of API...

Axyntis Group, founded in 2007, is France’s leading independent multi-site player in fine chemicals with a €90 million annual turnover. Axyntis has become a key producer of APIs in France through acquisitions & partnerships. It has two divisions (dyes and fine chemicals) and places a strong focus on diversification and innovation. It operates 3 cGMP sites in France, of which 2 are FDA-inspected. It provides CDMO services to its partners for their API or advanced intermediate projects, from early-stage development to the commercial phase, including preparative chromatography (Kyrapharm subsidiary). It also commercializes proprietary APIs.
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03

Antibody Engineering
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d-Amphetamine Sulfate

About the Company : Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world. With over 35 years...

Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world. With over 35 years of API development and manufacturing expertise, a growing team of more than 1,200 experts and a strong presence in the USA and Europe, we are tried and trusted across branded and generic API markets. We put all of our energy and experience into being your partner of choice. We create value for customers through manufacturing excellence, reliable quality and innovative science. Our people are the experts that our customers enjoy working with.
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04

Antibody Engineering
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AMPHETAMINE SULFATE

About the Company : Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world. With over 35 years...

Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world. With over 35 years of API development and manufacturing expertise, a growing team of more than 1,200 experts and a strong presence in the USA and Europe, we are tried and trusted across branded and generic API markets. We put all of our energy and experience into being your partner of choice. We create value for customers through manufacturing excellence, reliable quality and innovative science. Our people are the experts that our customers enjoy working with.
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05

Antibody Engineering
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Amphetasul

About the Company : Chr. Olesen Synthesis is a Danish manufacturer of APIs and advanced intermediates. Chr. Olesen Synthesis was established in 2012 after the Chr. Olesen Group acquisition of the mult...

Chr. Olesen Synthesis is a Danish manufacturer of APIs and advanced intermediates. Chr. Olesen Synthesis was established in 2012 after the Chr. Olesen Group acquisition of the multi-purpose synthetic production facility just south of Copenhagen. Chr. Olesen Synthesis is initially active with API’s comprising of molecules like Hydromorphone, Codeine Phosphate, Pramipexole, Terbinafine Risedronate, Tolfenamic Acid, Amphetamine derivatives and advanced intermediates for Buprenorphine and Tamsulosin.
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06

Curia

U.S.A
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Curia

U.S.A
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Amphetamine

About the Company : Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners tur...

Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners turn their ideas into real-world impact. We partner closely with pharmaceutical and biotechnology companies to boost business performance and improve patients’ lives. From early discovery and development through manufacturing and commercialization, our suite of custom solutions allows us to tailor every engagement to your precise needs, whether that’s an independent project or an opportunity that cuts across the drug continuum.
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07

Antibody Engineering
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Amphetamine Sulfate

About the Company : We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to m...

We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to market while improving the lives of their patients across the world. Our objective is to help our customers create a better world as the partner of choice to develop and manufacture complex and challenging substances, highly potent active ingredients, and breaking new ground with innovative vitamin, healthcare, and industrial products.
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08

Antibody Engineering
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Amphetamine phosphate

About the Company : We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to m...

We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to market while improving the lives of their patients across the world. Our objective is to help our customers create a better world as the partner of choice to develop and manufacture complex and challenging substances, highly potent active ingredients, and breaking new ground with innovative vitamin, healthcare, and industrial products.
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09

Antibody Engineering
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Amphetasul

About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to addr...

Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, steming from nearly 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future. Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients.
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10

Antibody Engineering
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Amphetamine

About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to addr...

Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, steming from nearly 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future. Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients.
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API Reference Price

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14-Feb-2022
08-Oct-2024
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

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Drugs in Development

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Details:

Dextroamphetamine Sulfate is a non-catecholamine sympathomimetic amines with CNS stimulant activity. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.


Lead Product(s): Amphetamine,Dextroamphetamine Saccharate,Amphetamine Aspartate

Therapeutic Area: Psychiatry/Psychology Brand Name: Amphetamine-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 24, 2023

Granules India

01

Antibody Engineering
Not Confirmed

Lead Product(s) : Amphetamine,Dextroamphetamine Saccharate,Amphetamine Aspartate

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Dextroamphetamine Sulfate is a non-catecholamine sympathomimetic amines with CNS stimulant activity. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extr...

Brand Name : Amphetamine-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

January 24, 2023

Granules India

Details:

FDA approved generic of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, for Attention Deficit Hyperactivity Disorder and Narcolepsy.


Lead Product(s): Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine

Therapeutic Area: Psychiatry/Psychology Brand Name: Adderall-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 30, 2021

Granules India

02

Antibody Engineering
Not Confirmed

Lead Product(s) : Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : FDA approved generic of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, for Attention Deficit Hyperactivity Disorder and Narcolepsy.

Brand Name : Adderall-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 30, 2021

Granules India

Details:

Adderall XR-Generic is a combination product of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate & amphetamine sulfate. It is indicated for ADHD.


Lead Product(s): Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine

Therapeutic Area: Psychiatry/Psychology Brand Name: Adderall XR-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 21, 2024

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03

Lupin Ltd

India
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Antibody Engineering
Not Confirmed

Lupin Ltd

India
arrow
Antibody Engineering
Not Confirmed

Details : Adderall XR-Generic is a combination product of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate & amphetamine sulfate. It is indicated for ADHD.

Brand Name : Adderall XR-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

November 21, 2024

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Details:

The agreement aims for the distribution and supply for Aytu's Adzenys XR-ODT and Cotempla XR-ODT product lines for the treatment of ADHD in Canada.


Lead Product(s): Amphetamine

Therapeutic Area: Psychiatry/Psychology Brand Name: Adzenys XR-ODT

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Lupin Pharma Canada

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement October 01, 2024

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04

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : The agreement aims for the distribution and supply for Aytu's Adzenys XR-ODT and Cotempla XR-ODT product lines for the treatment of ADHD in Canada.

Brand Name : Adzenys XR-ODT

Molecule Type : Small molecule

Upfront Cash : Undisclosed

October 01, 2024

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Details:

Tris Pharma and Perigon launched a direct-to-patient program, that allows patients and caregivers access to DYANAVEL XR (amphetamine) extended-release tablets through Perigon’s digital pharmacy and receive assistance and support to help navigate their treatment journey.


Lead Product(s): Amphetamine

Therapeutic Area: Psychiatry/Psychology Brand Name: Dyanavel XR

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Perigon Pharmacy 360

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership October 30, 2023

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05

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : Tris Pharma and Perigon launched a direct-to-patient program, that allows patients and caregivers access to DYANAVEL XR (amphetamine) extended-release tablets through Perigon’s digital pharmacy and receive assistance and support to help navigate their ...

Brand Name : Dyanavel XR

Molecule Type : Small molecule

Upfront Cash : Undisclosed

October 30, 2023

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Details:

Under the agreement, Aardvark will acquire certain assets and intellectual property of the Company that pertain to ADAIR, a proprietary abuse-deterrent formulation of immediate release dextroamphetamine, for the development of certain follow-on pipeline programs.


Lead Product(s): Amphetamine

Therapeutic Area: Psychiatry/Psychology Brand Name: ADAIR

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Aardvark Therapeutics

Deal Size: $80.0 million Upfront Cash: Undisclosed

Deal Type: Agreement August 23, 2023

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06

GRI Bio

U.S.A
arrow
Antibody Engineering
Not Confirmed

GRI Bio

U.S.A
arrow
Antibody Engineering
Not Confirmed

Details : Under the agreement, Aardvark will acquire certain assets and intellectual property of the Company that pertain to ADAIR, a proprietary abuse-deterrent formulation of immediate release dextroamphetamine, for the development of certain follow-on pipeline ...

Brand Name : ADAIR

Molecule Type : Small molecule

Upfront Cash : Undisclosed

August 23, 2023

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Details:

Under the agreement, Medomie will commercialize Adzenys XR-ODT (amphetamine) and Cotempla XR-ODT (methylphenidate) in Israel and the Palestinian Authority.


Lead Product(s): Amphetamine

Therapeutic Area: Psychiatry/Psychology Brand Name: Adzenys XR

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Aytu BioPharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement July 31, 2023

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Medomie

Israel
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Antibody Engineering
Not Confirmed

Medomie

Israel
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Antibody Engineering
Not Confirmed

Details : Under the agreement, Medomie will commercialize Adzenys XR-ODT (amphetamine) and Cotempla XR-ODT (methylphenidate) in Israel and the Palestinian Authority.

Brand Name : Adzenys XR

Molecule Type : Small molecule

Upfront Cash : Undisclosed

July 31, 2023

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Details:

Under the agreement, Glenmark will distribute Cediprof's FDA approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), the generic version of Adderall® Tablets.


Lead Product(s): Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine

Therapeutic Area: Psychiatry/Psychology Brand Name: Adderall-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Cediprof

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement March 09, 2023

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Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : Under the agreement, Glenmark will distribute Cediprof's FDA approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), the generic version...

Brand Name : Adderall-Generic

Molecule Type : Small molecule

Upfront Cash : Undisclosed

March 09, 2023

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Details:

Xelstrym™ (dextroamphetamine) is a first and only FDA-approved, once-daily central nervous system stimulant transdermal patch for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.


Lead Product(s): Amphetamine

Therapeutic Area: Psychiatry/Psychology Brand Name: Xelstrym

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 10, 2023

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09

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : Xelstrym™ (dextroamphetamine) is a first and only FDA-approved, once-daily central nervous system stimulant transdermal patch for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.

Brand Name : Xelstrym

Molecule Type : Small molecule

Upfront Cash : Not Applicable

January 10, 2023

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Details:

Dyanavel XR oral suspension (amphetamine) is a CNS stimulant that affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control used for the treatment of attention deficit hyperactivity disorder (ADHD) in people 6 years and older.


Lead Product(s): Amphetamine

Therapeutic Area: Psychiatry/Psychology Brand Name: Dyanavel XR

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Pediatrix Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership December 01, 2022

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Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : Dyanavel XR oral suspension (amphetamine) is a CNS stimulant that affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control used for the treatment of attention deficit hyperactivity disorder (ADHD) in people 6 years a...

Brand Name : Dyanavel XR

Molecule Type : Small molecule

Upfront Cash : Undisclosed

December 01, 2022

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Canada

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01

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DEXTROAMPHETAMINE SULFATE

Brand Name : DEXTROAMPHETAMINE

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging : 100/500

Approval Date :

Application Number : 2443236

Regulatory Info : Schedule G (CDSA I)

Registration Country : Canada

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Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DEXTROAMPHETAMINE SULFATE

Brand Name : TEVA-DEXTROAMPHETAMINE SR

Dosage Form : CAPSULE (SUSTAINED-RELEASE)

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2448319

Regulatory Info : Schedule G (CDSA I)

Registration Country : Canada

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Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DEXTROAMPHETAMINE SULFATE

Brand Name : TEVA-DEXTROAMPHETAMINE SR

Dosage Form : CAPSULE (SUSTAINED-RELEASE)

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number : 2448327

Regulatory Info : Schedule G (CDSA I)

Registration Country : Canada

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PALADIN PHARMA INC.

Country
Antibody Engineering
Not Confirmed
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PALADIN PHARMA INC.

Country
arrow
Antibody Engineering
Not Confirmed

DEXTROAMPHETAMINE SULFATE

Brand Name : DEXEDRINE

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 1924516

Regulatory Info : Schedule G (CDSA I)

Registration Country : Canada

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PALADIN PHARMA INC.

Country
Antibody Engineering
Not Confirmed
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PALADIN PHARMA INC.

Country
arrow
Antibody Engineering
Not Confirmed

DEXTROAMPHETAMINE SULFATE

Brand Name : DEXEDRINE SPANSULE

Dosage Form : CAPSULE (SUSTAINED-RELEASE)

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number : 1924567

Regulatory Info : Schedule G (CDSA I)

Registration Country : Canada

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06

PALADIN PHARMA INC.

Country
Antibody Engineering
Not Confirmed
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PALADIN PHARMA INC.

Country
arrow
Antibody Engineering
Not Confirmed

DEXTROAMPHETAMINE SULFATE

Brand Name : DEXEDRINE SPANSULE

Dosage Form : CAPSULE (SUSTAINED-RELEASE)

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 1924559

Regulatory Info : Schedule G (CDSA I)

Registration Country : Canada

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South Africa

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01

Adcock Ingram Limited

South Africa
Pharma, Lab & Chemical Expo
Not Confirmed
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Adcock Ingram Limited

South Africa
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Dexamfetamine Sulfate

Brand Name : Amfexa 20mg

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

Adcock Ingram Limited

South Africa
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

Adcock Ingram Limited

South Africa
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Dexamfetamine Sulfate

Brand Name : Amfexa 5mg

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

Adcock Ingram Limited

South Africa
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

Adcock Ingram Limited

South Africa
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Dexamfetamine Sulfate

Brand Name : Amfexa 10mg

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Listed Dossiers

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01

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Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Amphetamine

Brand Name :

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

01

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Amphetamine

Dosage : Tablet

Dosage Strength : 5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Strides Pharma Science

02

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Amphetamine

Brand Name :

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

02

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Amphetamine

Dosage : Tablet

Dosage Strength : 10MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Strides Pharma Science

03

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Amphetamine

Brand Name :

Dosage Form : Tablet

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

03

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Amphetamine

Dosage : Tablet

Dosage Strength : 15MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Strides Pharma Science

04

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

Amphetamine

Brand Name : Adderall

Dosage Form : Tablet

Dosage Strength : 7.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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04

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

Amphetamine

Dosage : Tablet

Dosage Strength : 7.5MG

Brand Name : Adderall

Approval Date :

Application Number :

Registration Country : U.S.A

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05

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

Amphetamine

Brand Name : Adderall

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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05

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

Amphetamine

Dosage : Tablet

Dosage Strength : 10MG

Brand Name : Adderall

Approval Date :

Application Number :

Registration Country : U.S.A

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06

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

Amphetamine

Brand Name : Adderall

Dosage Form : Tablet

Dosage Strength : 12.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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06

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

Amphetamine

Dosage : Tablet

Dosage Strength : 12.5MG

Brand Name : Adderall

Approval Date :

Application Number :

Registration Country : U.S.A

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07

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Amphetamine; Dextroamphetamine

Brand Name :

Dosage Form : Tablet

Dosage Strength :

Packaging : Size: 100s

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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07

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

Amphetamine; Dextroamphetamine

Dosage : Tablet

Dosage Strength :

Brand Name :

Approval Date :

Application Number :

Registration Country : U.S.A

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08

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

Amphetamine; Dextroamphetamine

Brand Name :

Dosage Form : Tablet

Dosage Strength :

Packaging : Size: 100s

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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08

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

Amphetamine; Dextroamphetamine

Dosage : Tablet

Dosage Strength :

Brand Name :

Approval Date :

Application Number :

Registration Country : U.S.A

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09

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

Amphetasul

Brand Name :

Dosage Form : Extended Release Capsu...

Dosage Strength : 5MG

Packaging : Size: 100s

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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09

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

Amphetasul

Dosage : Extended Release Capsu...

Dosage Strength : 5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : U.S.A

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Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

Amphetasul

Brand Name :

Dosage Form : Extended Release Capsu...

Dosage Strength : 10MG

Packaging : Size: 100s

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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10

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

Amphetasul

Dosage : Extended Release Capsu...

Dosage Strength : 10MG

Brand Name :

Approval Date :

Application Number :

Registration Country : U.S.A

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG

USFDA APPLICATION NUMBER - 17078

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15MG

USFDA APPLICATION NUMBER - 17078

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG

USFDA APPLICATION NUMBER - 17078

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DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - EQ 1.25MG BASE/ML

USFDA APPLICATION NUMBER - 204325

read-more

DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 12.5MG BASE

USFDA APPLICATION NUMBER - 204326

read-more

DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 15.7MG BASE

USFDA APPLICATION NUMBER - 204326

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DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 18.8MG BASE

USFDA APPLICATION NUMBER - 204326

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DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 3.1MG BASE

USFDA APPLICATION NUMBER - 204326

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DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 6.3MG BASE

USFDA APPLICATION NUMBER - 204326

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DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 9.4MG BASE

USFDA APPLICATION NUMBER - 204326

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DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - 2MG/ML;EQ 0.5MG BASE/ML

USFDA APPLICATION NUMBER - 208147

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG;EQ 3MG BASE

USFDA APPLICATION NUMBER - 210526

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG;EQ 4MG BASE

USFDA APPLICATION NUMBER - 210526

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG;EQ 1MG BASE

USFDA APPLICATION NUMBER - 210526

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG;EQ 2MG BASE

USFDA APPLICATION NUMBER - 210526

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 1.2...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 1.25MG;1.25MG;1.25MG;1.25MG

USFDA APPLICATION NUMBER - 21303

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2.5...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2.5MG;2.5MG;2.5MG;2.5MG

USFDA APPLICATION NUMBER - 21303

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.7...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.75MG;3.75MG;3.75MG;3.75MG

USFDA APPLICATION NUMBER - 21303

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG;5MG;5MG;5MG

USFDA APPLICATION NUMBER - 21303

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 6.2...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 6.25MG;6.25MG;6.25MG;6.25MG

USFDA APPLICATION NUMBER - 21303

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7.5...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7.5MG;7.5MG;7.5MG;7.5MG

USFDA APPLICATION NUMBER - 21303

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