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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 22 USDMF, 3 JDMF, 9 EU WC, 4 KDMF, 13 NDC API, 23 Listed Suppliers, $ API Reference Price

40 API Suppliers
22 USDMF
3 JDMF
9 EU WC
4 KDMF
13 NDC API
23 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

11 Drugs in Development

11 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

90 FDF Dossiers, 34 FDA Orange Book, 20 Europe, 2 Canada, 6 Australia, 7 South Africa, 21 Listed Dossiers

90 FDF Dossiers
34 FDA Orange Book
20 Europe
2 Canada
6 Australia
7 South Africa
21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 300MG;EQ 0.5MG BASE, SOLUTION;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML), POWDER;INTRAVENOUS - EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL, SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML), INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
CAPSULE;ORAL - 300MG;EQ 0.5MG BASE
SOLUTION;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
POWDER;INTRAVENOUS - EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL
SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)
INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 15 SPI Pharma, 7 DKSH, 3 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 9 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 3 DFE Pharma, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 6 Kerry, 3 Lonza Capsugel, 9 Microlex e.U, 1 NEWEDGE Overseas, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 22 Roquette, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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47 Fillers, Diluents & Binders, 23 Direct Compression, 18 Lubricants & Glidants, 17 Thickeners and Stabilizers, 17 Disintegrants & Superdisintegrants, 14 Taste Masking, 14 Chewable & Orodispersible Aids, 14 Co-Processed Excipients, 11 Film Formers & Plasticizers, 11 Coating Systems & Additives, 11 Parenteral, 10 Granulation, 8 Empty Capsules, 7 Controlled & Modified Release, 3 API Stability Enhancers, 3 Emulsifying Agents, 2 Solubilizers, 2 Coloring Agents, 2 Rheology Modifiers, 1 Soft Gelatin, 1 Topical

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 62 NEWS #PharmaBuzz

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2 DATA COMPILATION #PharmaFlow
62 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 18 Finished Drug Prices, 10 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
18 Finished Drug Prices
10 Annual Reports

MARKET PLACE

7 APIs, 6 FDF Dossiers

marketPlace
7 APIs
6 FDF Dossiers

PATENTS & EXCLUSIVITIES

76 US Patents, 3 Health Canada Patents

patents
76 US Patents
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

7 USP , 7 Others

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7 USP
7 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 680,068

MARKET PLACE

API

FDF

11INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

11DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

487,961

Annual Reports (USD Million)

1,368

Finished Drug Prices

147 RELATED EXCIPIENT COMPANIES

236EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 135729-62-3, Palonosetron hcl, Aloxi, Onicit, Palonosetron (hydrochloride), Rs-25259-197

Molecular Formula

C₁₉H₂₅ClN₂O

Molecular Weight

332.9 g/mol

InChI Key

OLDRWYVIKMSFFB-SSPJITILSA-N

FDA UNII

23310D4I19

Isoquinoline and quinuclidine derivative that acts as a 5-HT3 RECEPTOR antagonist. It is used in the prevention of nausea and vomiting induced by cytotoxic chemotherapy, and for the prevention of post-operative nausea and vomiting.

1 2D Structure

Palonosetron

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(3aS)-2-[(3S)-1-azabicyclo[2.2.2]octan-3-yl]-3a,4,5,6-tetrahydro-3H-benzo[de]isoquinolin-1-one;hydrochloride

2.1.2 InChI

InChI=1S/C19H24N2O.ClH/c22-19-16-6-2-4-14-3-1-5-15(18(14)16)11-21(19)17-12-20-9-7-13(17)8-10-20;/h2,4,6,13,15,17H,1,3,5,7-12H2;1H/t15-,17-;/m1./s1

2.1.3 InChI Key

OLDRWYVIKMSFFB-SSPJITILSA-N

2.1.4 Canonical SMILES

C1CC2CN(C(=O)C3=CC=CC(=C23)C1)C4CN5CCC4CC5.Cl

2.1.5 Isomeric SMILES

C1C[C@@H]2CN(C(=O)C3=CC=CC(=C23)C1)[C@@H]4CN5CCC4CC5.Cl

2.2 Other Identifiers

2.2.1 UNII

23310D4I19

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 2-(1-azabicyclo(2.2.2)oct-3-yl)-2,3,3a,4,5,6-hexahydro-1h-benz(de)isoquinolin-1-one

2. 2-qhbiqo

3. Aloxi

4. Palonosetron

5. Palonosetron, (3r)-

6. Palonosetron, (r-(r*,r*))-isomer

7. Palonosetron, (r-(r*,s*))-isomer

8. Palonosetron, (s-(r*,s*))-isomer

9. Rs 25233 197

10. Rs 25233 198

11. Rs 25233-197

12. Rs 25233-198

13. Rs 25233197

14. Rs 25233198

15. Rs 25259

16. Rs 25259 197

17. Rs 25259 198

18. Rs 25259-197

19. Rs 25259-198

20. Rs 25259197

21. Rs 25259198

22. Rs-25233-197

23. Rs-25233-198

24. Rs-25259

25. Rs-25259-197

26. Rs-25259-198

27. Rs25233197

28. Rs25233198

29. Rs25259

30. Rs25259197

31. Rs25259198

2.3.2 Depositor-Supplied Synonyms

1. 135729-62-3

2. Palonosetron Hcl

3. Aloxi

4. Onicit

5. Palonosetron (hydrochloride)

6. Rs-25259-197

7. (s,s)-palonosetron Hydrochloride

8. Palonocetron Hydrochloride

9. Palonosetron (as Hydrochloride)

10. Chebi:85157

11. Rs 25259-197

12. (3as)-2-(3s)-1-azabicyclo[2.2.2]oct-3-yl-2,3,3a,4,5,6-hexahydro-1h-benz[de]isoquinolin-1-one Monohydrochloride

13. (3as)-2-[(3s)-1-azabicyclo[2.2.2]octan-3-yl]-3a,4,5,6-tetrahydro-3h-benzo[de]isoquinolin-1-one;hydrochloride

14. 1h-benz[de]isoquinolin-1-one, 2-[(3s)-1-azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-, Hydrochloride (1:1), (3as)-

15. 23310d4i19

16. Aloxi (tn)

17. Dsstox_cid_26610

18. Dsstox_rid_81765

19. Dsstox_gsid_46610

20. (3as)-2,3,3a,4,5,6-hexahydro-2-((3s)-3-quinuclidinyl)-1h-benz(de)isoquinolin-1-one Monohydrochloride

21. (s)-2-((s)-quinuclidin-3-yl)-2,3,3a,4,5,6-hexahydro-1h-benzo[de]isoquinolin-1-one Hydrochloride

22. (r,s)-palonosetron Hcl

23. (s,r)-palonosetron Hcl

24. Cas-135729-62-3

25. Palonosetron Related Compound C

26. Palonosetron Related Compound D

27. Onicita

28. Paloxi

29. Palonosetron Hydrochloride [usan]

30. Unii-23310d4i19

31. Palonosetron Hydrochloride [usan:jan]

32. Palonosetronhydrochloride

33. Ncgc00166415-01

34. Chembl1720

35. Mls001424202

36. Schembl182478

37. Rs 25259 197

38. Dtxsid8046610

39. (3as)-palonosetron Hydrochloride

40. Palonosetron Hydrochloride- Bio-x

41. Palonosetron Hydrochloride (aloxi)

42. Ex-a4360

43. Hy-a0021

44. Tox21_112421

45. Mfcd00939524

46. Nsc743769

47. S3050

48. Palonosetron Hydrochloride (jan/usp)

49. Akos015895112

50. Akos026751493

51. Tox21_112421_1

52. Ac-1293

53. Ccg-101081

54. Ccg-221268

55. Cs-0621

56. Nc00331

57. Palonosetron Hydrochloride [mi]

58. Palonosetron Hydrochloride [jan]

59. Ncgc00166415-03

60. (3as)-2-[(3s)-1-azabicyclo[2.2.2]octan-3-yl]-3a,4,5,6-tetrahydro-3h-benzo[de]isoquinolin-1-one Hydrochloride

61. As-75066

62. Bp164227

63. Palonosetron Hydrochloride [mart.]

64. Rs 25259

65. Smr000469233

66. Palonosetron Hydrochloride [usp-rs]

67. Palonosetron Hydrochloride [who-dd]

68. Palonosetron Hydrochloride, >=98% (hplc)

69. P-225

70. P2051

71. Palonosetron Hydrochloride [ema Epar]

72. D05343

73. Palonosetron Hydrochloride [orange Book]

74. 729p623

75. Akynzeo Component Palonosetron Hydrochloride

76. Palonosetron Hydrochloride [usp Monograph]

77. 7-amino-3-(hydroxymethyl)-3-cephem-4-carboxylicacid

78. Palonosetron Hydrochloride Component Of Akynzeo

79. Q27158366

80. (s,r)-palonosetron Hydrochloride Contains Up To ~35% (r,r)-isomer

81. 1h-benz[de]isoquinolin-1-one,3,3a,4,5,6-hexahydro-, (3as)- Hydrochloride

82. 1h-benz[de]isoquinolin-1-one,3,3a,4,5,6-hexahydro-, [s-(r*,r*)]-, Hydrochloride

83. Palonosetron Hydrochloride, United States Pharmacopeia (usp) Reference Standard

84. (3as)-2-[(3s)-1-azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1h-benz[de]isoquinolin-1-one Hydrochloride

85. (3as)-2-[(3s)-1-azabicyclo[2.2.2]octan-3-yl]-2,3,3a,4,5,6-hexahydro-1h-benzo[de]isoquinolin-1-one--hydrogen Chloride (1/1)

86. (3as)-2-[(3s)-1-azabicyclo[2.2.2]octan-3-yl]-3a,4,5,6-tetrahydro-3h-benzo[de]isoquinolin-1-one;hydrochloride.

87. (3as)-2-[(s)-1-azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1h-benz[de]isoquinoline Hydrochloride

88. (3s)-3-[(3as)-1-oxo-3a,4,5,6-tetrahydro-1h-benzo[de]isoquinolin-2(3h)-yl]-1-azabicyclo[2.2.2]octan-1-ium Chloride

89. (5s)-3-[(3s)-1-azabicyclo[2.2.2]octan-3-yl]-3-azatricyclo[7.3.1.0?,(1)(3)]trideca-1(13),9,11-trien-2-one Hydrochloride

90. 1h-benz(de)isoquinolin-1-one, 2-(3s)-1-azabicyclo(2.2.2)oct-3-yl-2,3,3a,4,5,6-hexahydro-, Monohydrochloride, (3as)-

2.4 Create Date

2006-07-28

3 Chemical and Physical Properties

Molecular Formula	C₁₉H₂₅ClN₂O
Molecular Weight	332.9 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	1
Exact Mass	332.1655411 g/mol
Monoisotopic Mass	332.1655411 g/mol
Topological Polar Surface Area	23.6 Å²
Heavy Atom Count	23
Formal Charge	0
Complexity	456
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Palonosetron hydrochloride
Drug Label	ALOXI (palonosetron hydrochloride) is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]...
Active Ingredient	Palonosetron hydrochloride
Dosage Form	Injectable
Route	injection
Strength	0.25mg/0.25ml; 0.25mg/5ml; 0.05mg/ml; 0.075mg/1.5ml
Market Status	Tentative Approval
Company	Teva Pharms; Dr Reddys Labs

2 of 2
Drug Name	Palonosetron hydrochloride
Drug Label	ALOXI (palonosetron hydrochloride) is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]...
Active Ingredient	Palonosetron hydrochloride
Dosage Form	Injectable
Route	injection
Strength	0.25mg/0.25ml; 0.25mg/5ml; 0.05mg/ml; 0.075mg/1.5ml
Market Status	Tentative Approval
Company	Teva Pharms; Dr Reddys Labs

4.2 Drug Indication

Aloxi is indicated in adults for:

- the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,

- the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Aloxi is indicated in paediatric patients 1 month of age and older for:

- the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antiemetics

Drugs used to prevent NAUSEA or VOMITING. (See all compounds classified as Antiemetics.)

Serotonin 5-HT3 Receptor Antagonists

Drugs that bind to but do not activate SEROTONIN 5-HT3 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT3 RECEPTOR AGONISTS. (See all compounds classified as Serotonin 5-HT3 Receptor Antagonists.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Serotonin-3 Receptor Antagonist [EPC]; Serotonin 3 Receptor Antagonists [MoA]

5.3 ATC Code

A04AA05

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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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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - 300MG;EQ 0.5MG BASE

USFDA APPLICATION NUMBER - 205718

DOSAGE - SOLUTION;INTRAVENOUS - EQ 0.25MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

USFDA APPLICATION NUMBER - 208109

DOSAGE - POWDER;INTRAVENOUS - EQ 235MG BASE/V...DOSAGE - POWDER;INTRAVENOUS - EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL

USFDA APPLICATION NUMBER - 210493

DOSAGE - SOLUTION;INTRAVENOUS - EQ 235MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)

USFDA APPLICATION NUMBER - 210493

DOSAGE - INJECTABLE;INTRAVENOUS - EQ 0.075MG ...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21372

DOSAGE - INJECTABLE;INTRAVENOUS - EQ 0.25MG B...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21372

DOSAGE - CAPSULE;ORAL - EQ 0.5MG BASE **Feder...DOSAGE - CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22233

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ABOUT THIS PAGE

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

40 API Suppliers

22 USDMF

3 JDMF

9 EU WC

4 KDMF

13 NDC API

23 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

11 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

90 FDF Dossiers

34 FDA Orange Book

20 Europe

2 Canada

6 Australia

7 South Africa

21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 300MG;EQ 0.5MG BASE

SOLUTION;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

POWDER;INTRAVENOUS - EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL

SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)

INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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EXCIPIENTS BY APPLICATIONS

47 Fillers, Diluents & Binders

23 Direct Compression

18 Lubricants & Glidants

17 Thickeners and Stabilizers

17 Disintegrants & Superdisintegrants

14 Taste Masking

14 Chewable & Orodispersible Aids

14 Co-Processed Excipients

11 Film Formers & Plasticizers

INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons