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ACTIVE PHARMA INGREDIENTS

19 API Suppliers, 6 USDMF, 1 EU WC, 7 NDC API, 15 Listed Suppliers, $ API Reference Price

19 API Suppliers
6 USDMF
1 EU WC
7 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

18 Drugs in Development

18 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

24 FDF Dossiers, 8 FDA Orange Book, 5 Europe, 3 Canada, 6 Australia, 2 South Africa

24 FDF Dossiers
8 FDA Orange Book
5 Europe
3 Canada
6 Australia
2 South Africa

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 0.5MG, TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2MG

drugProductComposition
TABLET;ORAL - EQ 0.5MG
TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 2MG

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GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 5 Finished Drug Prices, 6 Annual Reports

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1 US Medicaid Prescriptions
5 Finished Drug Prices
6 Annual Reports

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PATENTS & EXCLUSIVITIES

87 US Patents, 40 US Exclusivities, 3 Health Canada Patents

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87 US Patents
40 US Exclusivities
3 Health Canada Patents

Polpharma Trametinib

Synopsis

ACTIVE PHARMA INGREDIENTS

19

API Suppliers

6

USDMF

0

CEP/COS

CEP/COS Certifications

0

JDMF

1

EU WC

0

KDMF

7

NDC API

0

VMF

15

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 562,956

MARKET PLACE

3

API

0

FDF

11INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

24

FDF Dossiers

8

FDA Orange Book

FDA (Orange Book)

5

Europe

3

Canada

6

Australia

2

South Africa

0

Listed Dossiers

18DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

PATENTS & EXCLUSIVITIES

87

US Patents

40

US Exclusivities

3

Health Canada Patents

DIGITAL CONTENT

5

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

48

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

159,068,731

Annual Reports (USD Million)

8,845

Finished Drug Prices

184 RELATED EXCIPIENT COMPANIES

316EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 871700-17-3, Gsk1120212, Mekinist, Gsk-1120212, Jtp 74057, Jtp-74057

Molecular Formula

C₂₆H₂₃FIN₅O₄

Molecular Weight

615.4 g/mol

InChI Key

LIRYPHYGHXZJBZ-UHFFFAOYSA-N

FDA UNII

33E86K87QN

Trametinib

Trametinib is an orally bioavailable inhibitor of mitogen-activated protein kinase kinase (MAP2K; MAPK/ERK kinase; MEK) 1 and 2, with potential antineoplastic activity. Upon oral administration, trametinib specifically binds to and inhibits MEK 1 and 2, resulting in an inhibition of growth factor-mediated cell signaling and cellular proliferation in various cancers. MEK 1 and 2, dual specificity serine/threonine and tyrosine kinases often upregulated in various cancer cell types, play a key role in the activation of the RAS/RAF/MEK/ERK signaling pathway that regulates cell growth.

Trametinib is a Kinase Inhibitor. The mechanism of action of trametinib is as a Protein Kinase Inhibitor.

1 2D Structure

Trametinib

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N-[3-[3-cyclopropyl-5-(2-fluoro-4-iodoanilino)-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1-yl]phenyl]acetamide

2.1.2 InChI

InChI=1S/C26H23FIN5O4/c1-13-22-21(23(31(3)24(13)35)30-20-10-7-15(28)11-19(20)27)25(36)33(17-8-9-17)26(37)32(22)18-6-4-5-16(12-18)29-14(2)34/h4-7,10-12,17,30H,8-9H2,1-3H3,(H,29,34)

2.1.3 InChI Key

LIRYPHYGHXZJBZ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=C2C(=C(N(C1=O)C)NC3=C(C=C(C=C3)I)F)C(=O)N(C(=O)N2C4=CC=CC(=C4)NC(=O)C)C5CC5

2.2 Other Identifiers

2.2.1 UNII

33E86K87QN

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Gsk 1120212

2. Gsk-1120212

3. Gsk1120212

4. Jtp 74057

5. Jtp-74057

6. Jtp74057

2.3.2 Depositor-Supplied Synonyms

1. 871700-17-3

2. Gsk1120212

3. Mekinist

4. Gsk-1120212

5. Jtp 74057

6. Jtp-74057

7. Gsk 1120212

8. Trametinib (gsk1120212)

9. N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2h)-yl]phenyl]acetamide

10. Gsk212

11. Tmt212

12. Trametinib [usan]

13. Chebi:75998

14. Tmt-212

15. 33e86k87qn

16. Trametinib (usan)

17. N-(3-{3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2h)-yl}phenyl)acetamide

18. N-[3-[3-cyclopropyl-5-(2-fluoro-4-iodoanilino)-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1-yl]phenyl]acetamide

19. Acetamide, N-(3-(3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-3,4,6,7-tetrahydro-6,8- Dimethyl-2,4,7-trioxopyrido(4,3-d)pyrimidin-1(2h)-yl)phenyl)-

20. N-(3-(3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2h)-yl)phenyl)acetamide

21. Unii-33e86k87qn

22. Trametinib [usan:inn]

23. Trametinibum

24. Jtp74057

25. N-(3-(3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7- Tetrahydropyrido(4,3-d)pyrimidin-1(2h)-yl)phenyl)acetamide

26. N-(3-(3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido(4,3-d)pyrimidin-1(2h)-yl)phenyl)acetamide

27. N-(3-{3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7- Tetrahydropyrido(4,3-d)pyrimidin-1(2h)-yl}phenyl)acetamide

28. Qom

29. Trametinib [mi]

30. Trametinib (gsk1120212jtp 74057)

31. Trametinib [inn]

32. Trametinib [vandf]

33. Trametinib [who-dd]

34. Schembl170938

35. Gtpl6495

36. Gsk1120212 (trametinib)

37. Chembl2103875

38. Ex-a022

39. Bcpp000218

40. Dtxsid901007381

41. Hms3295i05

42. Hms3656j11

43. Bcp02307

44. Bdbm50531540

45. Mfcd17215075

46. Nsc758246

47. Nsc800956

48. S2673

49. Zinc43100709

50. Akos015850628

51. Am90271

52. Ccg-264976

53. Cs-0060

54. Db08911

55. Ex-5957

56. Nsc-758246

57. Nsc-800956

58. Sb16553

59. Ncgc00263180-01

60. Ncgc00263180-07

61. Ncgc00263180-14

62. Ac-25891

63. As-19382

64. Hy-10999

65. N-[3-[3-cyclopropyl-5-(2-fluoro-4-iodo-anilino)-6,8-dimethyl-2,4,7-trioxo-pyrido[4,3-d]pyrimidin-1-yl]phenyl]acetamide

66. Ft-0688438

67. Sw218089-2

68. A25168

69. D10175

70. Gsk1120212 - Jtp-74057

71. Gsk1120212,jtp-74057, Gsk212

72. Sr-01000941589

73. A1-01871

74. J-523325

75. Q7833138

76. Sr-01000941589-1

77. Brd-k12343256-001-01-4

78. Acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2h)-yl]phenyl]-

79. N-(3-(3-cyclopropyl-5-(2-fluoro-4-iodophenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2h)-yl)phenyl)acetamide

80. N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2h)-yl]phe Nyl]acetamide

81. N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-6,8-dimethyl-2,4,7-trioxopyrido[3,4-e]pyrimidin-1-yl]phenyl]acetamide

82. N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodoanilino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2h)-yl]phenyl}ethanimidic Acid

83. N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodophenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2h-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide

2.4 Create Date

2006-10-26

3 Chemical and Physical Properties

Molecular Formula	C₂₆H₂₃FIN₅O₄
Molecular Weight	615.4 g/mol
XLogP3	3.4
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	5
Exact Mass	615.07788 g/mol
Monoisotopic Mass	615.07788 g/mol
Topological Polar Surface Area	102 Å²
Heavy Atom Count	37
Formal Charge	0
Complexity	1090
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Mekinist
PubMed Health	Trametinib (By mouth)
Drug Classes	Antineoplastic Agent
Drug Label	Trametinib dimethyl sulfoxide is a kinase inhibitor. The chemical name is acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4- iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl- 2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]-, compound with 1,1-sul...
Active Ingredient	Trametinib dimethyl sulfoxide
Dosage Form	Tablet
Route	Oral
Strength	eq 1mg non-solvated parent; eq 0.5mg non-solvated parent; eq 2mg non-solvated parent
Market Status	Prescription
Company	Glaxosmithkline

2 of 2
Drug Name	Mekinist
PubMed Health	Trametinib (By mouth)
Drug Classes	Antineoplastic Agent
Drug Label	Trametinib dimethyl sulfoxide is a kinase inhibitor. The chemical name is acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4- iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl- 2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]-, compound with 1,1-sul...
Active Ingredient	Trametinib dimethyl sulfoxide
Dosage Form	Tablet
Route	Oral
Strength	eq 1mg non-solvated parent; eq 0.5mg non-solvated parent; eq 2mg non-solvated parent
Market Status	Prescription
Company	Glaxosmithkline

4.2 Drug Indication

Trametinib is indicated for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test [FDA]. In May 2018, it was approved for use with [DB08912] for the treatment of treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene.

FDA Label

* Melanoma:

Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4. 4 and 5. 1).

Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5. 1).

* Adjuvant treatment of melanoma:

Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.

* Non-small cell lung cancer (NSCLC):

Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Trametinib is an anticancer agent which causes apoptosis (or programmed cell death) and inhibits cell proliferation, which are both important in the treatment of malignancies.

5.2 MeSH Pharmacological Classification

Antineoplastic Agents

Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

Protein Kinase Inhibitors

Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

TRAMETINIB

5.3.2 FDA UNII

33E86K87QN

5.3.3 Pharmacological Classes

Protein Kinase Inhibitors [MoA]; Kinase Inhibitor [EPC]

5.4 ATC Code

L01EE01

L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01E - Protein kinase inhibitors

L01EE - Mitogen-activated protein kinase (mek) inhibitors

L01EE01 - Trametinib

5.5 Absorption, Distribution and Excretion

Absorption

Trametinib is readily absorbed. When an oral administration of trametinib was given to patients with BRAF V600 mutation-positive melanoma, peak plasma concentration occurred 1.5 hours post-dose (Tmax). A single 2 mg oral dose has a bioavailability of 72%. When a dose of 2mg/day is given, the peak plasma concentration (Cmax) is 22.2 ng/mL.

Route of Elimination

80% of the dose is excreted in the feces. <20% of the dose is excreted in the urine with <0.1% of the excreted dose in the form of the parent compound.

Volume of Distribution

Apparent volume of distribution (Vd/F) = 214 L

Clearance

Apparent clearance = 4.9 L/h

5.6 Metabolism/Metabolites

Trametinib is metabolized predominantly via deacetylation alone or with mono-oxygenation or in combination with glucuronidation biotransformation pathways in vitro. Deacetylation is likely mediated by hydrolytic enzymes, such as carboxyl-esterases or amidases. The cytochrome P450 enzyme system is not involved with the metabolism of trametinib. The predominant circulating component in the plasma is the parent drug.

5.7 Biological Half-Life

Elimination half-life = 3.9-4.8 days.

5.8 Mechanism of Action

Trametinib is a reversible, allosteric inhibitor of mitogen-activated extracellular signal regulated kinase 1 _(MEK1)_ and _MEK2_ activation and of_ MEK1_ and _MEK2_ kinase activity. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. Trametinib helps with melanoma with the BRAF V600E or V600K as the mutation results in the constitutive activation of the BRAF pathway which includes MEK1 and MEK2.

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[{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1666722600,"product":"TRAMETINIB DMSO TMD4 (TZ)","address":"MSN HOUSE, PLOT NO. C-24,INDUSTRIAL HYDERABAD","city":"HYDERABAD","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"ZAGREB","customer":"TO THE ORDER OF","customerCountry":"CROATIA","quantity":"0.55","actualQuantity":"550","unit":"GMS","unitRateFc":"500","totalValueFC":"273977.2","currency":"USD","unitRateINR":40989.090909090912,"date":"26-Oct-2022","totalValueINR":"22544000","totalValueInUsd":"273977.2","indian_port":"HYDERABAD AIR","hs_no":"29337990","bill_no":"5055026","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE, PLOT NO. C-24,INDUSTRIAL HYDERABAD, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1673893800,"product":"TRAMETINIB ACETIC ACID STAGE-III (US)","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"AUROBINDO PHARMA LIMITED","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"PHAROS LTD","customerCountry":"GREECE","quantity":"0.00","actualQuantity":"0.002","unit":"KGS","unitRateFc":"900000","totalValueFC":"1724.6","currency":"USD","unitRateINR":70500000,"date":"17-Jan-2023","totalValueINR":"141000","totalValueInUsd":"1724.6","indian_port":"HYDERABAD AIR","hs_no":"29335990","bill_no":"7023977","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1674844200,"product":"TRAMETINIB DIMETHYLSULFOXIDE (FORM-M)","address":"MSN HOUSE, PLOT NO. C-24,INDUSTRIAL HYDERABAD","city":"HYDERABAD","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"KUALA LUMPUR - INT\\'L","customer":"TO THE ORDER OF","customerCountry":"MALAYSIA","quantity":"0.38","actualQuantity":"0.38","unit":"KGS","unitRateFc":"475000","totalValueFC":"177679.7","currency":"USD","unitRateINR":38228947.368421055,"date":"28-Jan-2023","totalValueINR":"14527000","totalValueInUsd":"177679.7","indian_port":"HYDERABAD AIR","hs_no":"29337990","bill_no":"7330364","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MALAYSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE, PLOT NO. C-24,INDUSTRIAL HYDERABAD, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702233000,"product":"TRAMETINIB DIMETHYLSULFOXIDE (FORM-M)","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"MALTA","customer":"PHARMACARE PREMIUM","customerCountry":"MALTA","quantity":"0.25","actualQuantity":"0.25","unit":"KGS","unitRateFc":"650000","totalValueFC":"160565.8","currency":"USD","unitRateINR":53464000,"date":"11-Dec-2023","totalValueINR":"13366000","totalValueInUsd":"160565.8","indian_port":"Hyderabad Air","hs_no":"29337990","bill_no":"5953884","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723055400,"product":"TRAMETINIB DIMETHYL SULFOXIDE (GSK1120212B) 51000171 LOT: 291767 (FOC) (REFERANCE STANDARD)","address":"SANDOZ HOUSE,8TH FLOOR,","city":"MUMBAI,MAHARASHTRA","supplier":"NOVARTIS PHARMACEUTICAL MANUFACTURI","supplierCountry":"SLOVENIA","foreign_port":"LJUBLJANA - BRNIK","customer":"NOVARTIS PHARMACEUTICALS CORPORATION","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00025","unit":"KGS","unitRateFc":"3461840","totalValueFC":"951.8","currency":"EUR","unitRateINR":"319354760","date":"08-Aug-2024","totalValueINR":"79838.69","totalValueInUsd":"951.8","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"4949894","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVENIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LJUBLJANA - BRNIK","supplierAddress":"NG LLCVEROVSKOVA ULICA 57 1000 LJUBLJANALjubljana, SloveniaSDNF Slovenia","customerAddress":"SANDOZ HOUSE,8TH FLOOR,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - TABLET;ORAL - EQ 0.5MG

USFDA APPLICATION NUMBER - 204114

DOSAGE - TABLET;ORAL - EQ 1MG **Federal Regis...DOSAGE - TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 204114

DOSAGE - TABLET;ORAL - EQ 2MG

USFDA APPLICATION NUMBER - 204114

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