Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

How our clients use DrugPatentWatch

Generated: April 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074728

« Back to Dashboard
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

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
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
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

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How our clients use DrugPatentWatch

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted

Follow DrugPatentWatch:

Google Plus