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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074728

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NDA 074728 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 074728

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

Pharmacology for NDA: 074728

Medical Subject Heading (MeSH) Categories for 074728

Suppliers and Packaging for NDA: 074728

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 074728 ANDA Eon Labs, Inc. 0185-7400 0185-7400-85 1 VIAL, MULTI-DOSE in 1 CARTON (0185-7400-85) > 2.8 mL in 1 VIAL, MULTI-DOSE (0185-7400-14)
LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 074728 ANDA Sandoz Inc 0781-4003 0781-4003-32 1 KIT in 1 CARTON (0781-4003-32) * 1 mL in 1 PACKET * 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3006-42) > 2.8 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/0.2ML
Approval Date:Aug 4, 1998TE:APRLD:No


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