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Generated: June 27, 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, Teva Pharms Usa, and Sun Pharma Global, and is included in four NDAs. It is available from four 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. Six suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for NDA: 074728

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

Pharmacology for NDA: 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 VIAL, MULTI-DOSE in 1 CARTON (0781-3006-42) > 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:Aug 4, 1998TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Accenture
Fish and Richardson
McKinsey
AstraZeneca
Merck
Express Scripts
Harvard Business School
Covington
QuintilesIMS

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