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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078885

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NDA 078885 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-one 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 078885

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

Medical Subject Heading (MeSH) Categories for 078885

Suppliers and Packaging for NDA: 078885

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 078885 ANDA Sun Pharma Global FZE 47335-936 47335-936-40 1 KIT in 1 CARTON (47335-936-40) * 1 VIAL, MULTI-DOSE in 1 CARTON > 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/0.2ML
Approval Date:Mar 9, 2009TE:APRLD:No


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