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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075471

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NDA 075471 describes LEUPROLIDE ACETATE, which is a drug marketed by Genzyme, Sandoz, Sun Pharma Global, and Teva Pharms Usa, and is included in four NDAs. It is available from three suppliers. Additional details are available on the LEUPROLIDE ACETATE profile page.

The generic ingredient in LEUPROLIDE ACETATE is leuprolide acetate. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 075471
Tradename:LEUPROLIDE ACETATE
Applicant:Teva Pharms Usa
Ingredient:leuprolide acetate
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075471

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/0.2ML
Approval Date:Oct 25, 2000TE:APRLD:No

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