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Setid Ed2db562 Cfd2 4925 A5fd Fe5a2b7e1e0b Applno 20263 Form Powder Intramuscular Dosage 7 5mg - Drug Product Composition: Leuprolide

Leuprolide

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

99 API Suppliers, 30 USDMF, 15 CEP/COS, 5 JDMF, 6 EU WC, 11 KDMF, 60 NDC API, 27 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

52 Drugs in Development

52 Drugs in Development

FINISHED DOSAGE FORMULATIONS

158 FDF Dossiers, 35 FDA Orange Book, 52 Europe, 11 Canada, 11 Australia, 9 South Africa, 40 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

POWDER;INTRAMUSCULAR - 11.25MG, POWDER;INTRAMUSCULAR - 15MG, POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INTRAMUSCULAR - 30MG, POWDER;INTRAMUSCULAR - 45MG, POWDER;INTRAMUSCULAR - 7.5MG, POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG

RELATED EXCIPIENT COMPANIES

1 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 3 Actylis, 1 Finar

EXCIPIENTS BY APPLICATIONS

4 Parenteral, 2 Topical, 1 Solubilizers

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 38 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 30 Regulatory FDF Prices, 23 Annual Reports

MARKET PLACE

12 APIs, 9 FDF Dossiers

PATENTS & EXCLUSIVITIES

19 US Patents, 1 US Exclusivities, 9 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 JP, 3 Others

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USFDA APPLICATION NUMBER - 20263 / DOSAGE - POWDER;INTRAMUSCULAR - 7.5MG

Setid Ed2db562 Cfd2 4925 A5fd Fe5a2b7e1e0b Applno 20263 Form Powder Intramuscular Dosage 7 5mg - Drug Product Composition: Leuprolide

Leuprolide

Leuprolide

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

99 API Suppliers

30 USDMF

15 CEP/COS

5 JDMF

6 EU WC

11 KDMF

60 NDC API

27 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

52 Drugs in Development

FINISHED DOSAGE FORMULATIONS

158 FDF Dossiers

35 FDA Orange Book

52 Europe

11 Canada

11 Australia

9 South Africa

40 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

POWDER;INTRAMUSCULAR - 11.25MG

POWDER;INTRAMUSCULAR - 15MG

POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

POWDER;INTRAMUSCULAR - 30MG

POWDER;INTRAMUSCULAR - 45MG

POWDER;INTRAMUSCULAR - 7.5MG

POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG

INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG

RELATED EXCIPIENT COMPANIES

1 Nanjing Well Pharmaceutical

1 Kirsch Pharma

3 Actylis

1 Finar

EXCIPIENTS BY APPLICATIONS

4 Parenteral

2 Topical

1 Solubilizers

DIGITAL CONTENT

2 Data Compilation #PharmaFlow

38 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions

30 Regulatory FDF Prices

23 Annual Reports

MARKET PLACE

12 APIs

9 FDF Dossiers

PATENTS & EXCLUSIVITIES

19 US Patents

1 US Exclusivities

9 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM

1 JP

3 Others

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POWDER;INTRAMUSCULAR - 3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

POWDER;INTRAMUSCULAR - 7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons