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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 075721


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NDA 075721 describes LEUPROLIDE ACETATE, which is a drug marketed by Amneal, Eugia Pharma, Genzyme, Meitheal, Rk Pharma, Sandoz, Sun Pharm, and Invagen Pharms, and is included in eight NDAs. It is available from six 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. Nine suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 075721
Tradename:LEUPROLIDE ACETATE
Applicant:Genzyme
Ingredient:leuprolide acetate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075721

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1MG/0.2ML
Approval Date:Nov 29, 2001TE:RLD:No

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