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- 15MG, POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INTRAMUSCULAR - 30MG, POWDER;INTRAMUSCULAR - 45MG, POWDER;INTRAMUSCULAR - 7.5MG, POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL -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

$ Xls

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USFDA APPLICATION NUMBER - 203696 / DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG

Inactive Ingredients

Ingredient Name	AbbVie Inc.
ACETIC ACID(Q40Q9N063P)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
GELATIN, UNSPECIFIED(2G86QN327L)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYSORBATE 80(6OZP39ZG8H)
SILICON DIOXIDE(ETJ7Z6XBU4)
TALC(7SEV7J4R1U)
WATER(059QF0KO0R)

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