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Drug Product Composition: Leuprolide Acetate

Leuprolide Acetate

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ACTIVE PHARMA INGREDIENTS

45 API Suppliers, 29 USDMF, 15 CEP/COS, 5 JDMF, 4 EU WC, 10 KDMF, 60 NDC API, 21 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

17 Drugs in Development

17 Drugs in Development

FINISHED DOSAGE FORMULATIONS

178 FDF Dossiers, 34 FDA Orange Book, 75 Europe, 11 Canada, 11 Australia, 9 South Africa, 38 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- 15MG, POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INTRAMUSCULAR - 30MG, POWDER;INTRAMUSCULAR - 45MG, POWDER;INTRAMUSCULAR - 7.5MG, POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL -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, 3 Actylis, 1 Finar

EXCIPIENTS BY APPLICATIONS

3 Parenteral, 2 Topical, 1 Solubilizers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 34 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 38 Finished Drug Prices, 21 Annual Reports

MARKET PLACE

9 APIs, 7 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 1 US Exclusivities, 10 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 1 JP, 2 Others

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

Drug Product Composition: Leuprolide Acetate

Leuprolide Acetate

Leuprolide Acetate

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

45 API Suppliers

29 USDMF

15 CEP/COS

5 JDMF

4 EU WC

10 KDMF

60 NDC API

21 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

17 Drugs in Development

FINISHED DOSAGE FORMULATIONS

178 FDF Dossiers

34 FDA Orange Book

75 Europe

11 Canada

11 Australia

9 South Africa

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POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

3 Actylis

1 Finar

EXCIPIENTS BY APPLICATIONS

3 Parenteral

2 Topical

1 Solubilizers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow

34 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions

38 Finished Drug Prices

21 Annual Reports

MARKET PLACE

9 APIs

7 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents

1 US Exclusivities

10 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM

1 USP

1 JP

2 Others

Filters

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