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Setid 140399d0 4b28 4100 B792 3d1aa3c3e29c Applno 20981 Form Capsule Oral Dosage Eq 0 25mg Base - Drug Product Composition: Evotropin

Evotropin

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

19 API Suppliers, 6 USDMF, 1 JDMF, 4 KDMF, 3 NDC API, 12 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

45 Drugs in Development

45 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

89 FDF Dossiers, 22 FDA Orange Book, 48 Europe, 5 Canada, 4 Australia, 4 South Africa, 6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML), INJECTABLE;INJECTION - EQ 4MG BASE/VIAL, CAPSULE;ORAL - EQ 0.25MG BASE, CAPSULE;ORAL - EQ 1MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 14 SPI Pharma, 6 DKSH, 1 Gangwal Healthcare, 1 Pfanstiehl, 1 Capital Farma, 4 ACG Worldwide, 1 Actylis, 2 BASF, 1 CD Formulation, 3 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 1 Kerry, 3 Lonza Capsugel, 2 Microlex e.U, 1 Pluviaendo, 1 Qualicaps, 5 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

21 Fillers, Diluents & Binders, 12 Chewable & Orodispersible Aids, 11 Taste Masking, 10 Direct Compression, 8 Empty Capsules, 7 Disintegrants & Superdisintegrants, 6 Coating Systems & Additives, 6 Thickeners and Stabilizers, 5 Parenteral, 5 Solubilizers, 3 Co-Processed Excipients, 3 Granulation, 2 Coloring Agents, 2 Film Formers & Plasticizers, 2 Topical, 1 Controlled & Modified Release

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 21 News #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 12 Regulatory FDF Prices

MARKET PLACE

5 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 Health Canada Patents

2 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 Others

1 Others

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USFDA APPLICATION NUMBER - 20981 / DOSAGE - CAPSULE;ORAL - EQ 0.25MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPOTECAN HYDROCHLORIDE(UNII: 956S425ZCY) (TOPOTECAN - UNII:7M7YKX2N15)	TOPOTECAN	1mg \| 0.25mg

Inactive Ingredients

Ingredient Name	GlaxoSmithKline LLC	GlaxoSmithKline Manufacturing SpA
FERRIC OXIDE RED(1K09F3G675)
GELATIN, UNSPECIFIED(2G86QN327L)
GLYCERYL MONOSTEARATE(230OU9XXE4)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 140399d0 4b28 4100 B792 3d1aa3c3e29c Applno 20981 Form Capsule Oral Dosage Eq 0 25mg Base - Drug Product Composition: Evotropin

Evotropin

Evotropin

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

19 API Suppliers

6 USDMF

1 JDMF

4 KDMF

3 NDC API

12 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

45 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

89 FDF Dossiers

22 FDA Orange Book

48 Europe

5 Canada

4 Australia

4 South Africa

6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

INJECTABLE;INJECTION - EQ 4MG BASE/VIAL

CAPSULE;ORAL - EQ 0.25MG BASE

CAPSULE;ORAL - EQ 1MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

14 SPI Pharma

6 DKSH

1 Gangwal Healthcare

1 Pfanstiehl

1 Capital Farma

4 ACG Worldwide

1 Actylis

2 BASF

1 CD Formulation

3 Gangwal Chemicals

1 Ingredion Pharma Solutions

1 Kerry

3 Lonza Capsugel

2 Microlex e.U

1 Pluviaendo

1 Qualicaps

5 Roquette

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

21 Fillers, Diluents & Binders

12 Chewable & Orodispersible Aids

11 Taste Masking

10 Direct Compression

8 Empty Capsules

7 Disintegrants & Superdisintegrants

6 Coating Systems & Additives

6 Thickeners and Stabilizers

5 Parenteral

5 Solubilizers

3 Co-Processed Excipients

3 Granulation

2 Coloring Agents

2 Film Formers & Plasticizers

2 Topical

1 Controlled & Modified Release

DIGITAL CONTENT

1 Data Compilation #PharmaFlow

21 News #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions

12 Regulatory FDF Prices

SOLUTION;INTRAVENOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons