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Serving 500+ biopharmaceutical companies globally:

Dow
Teva
US Army
Farmers Insurance
Citi
Healthtrust
AstraZeneca
US Department of Justice
UBS
Moodys

Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019836

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NDA 019836 describes SUPPRELIN, which is a drug marketed by Shire and Endo Pharm and is included in two NDAs. There is one patent protecting this drug. Additional details are available on the SUPPRELIN profile page.

The generic ingredient in SUPPRELIN is histrelin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the histrelin acetate profile page.

Summary for NDA: 019836

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 0.2MG BASE/ML
Approval Date:Dec 24, 1991TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG BASE/ML
Approval Date:Dec 24, 1991TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:Dec 24, 1991TE:RLD:No

Expired Orange Book Patents for NDA: 019836

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire
SUPPRELIN
histrelin acetate
INJECTABLE;INJECTION019836-001Dec 24, 1991► Subscribe► Subscribe
Shire
SUPPRELIN
histrelin acetate
INJECTABLE;INJECTION019836-003Dec 24, 1991► Subscribe► Subscribe
Shire
SUPPRELIN
histrelin acetate
INJECTABLE;INJECTION019836-002Dec 24, 1991► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
QuintilesIMS
Julphar
US Army
Merck
Farmers Insurance
Daiichi Sankyo
US Department of Justice
Fish and Richardson
Argus Health

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