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

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Fish and Richardson
Federal Trade Commission
Cantor Fitzgerald
Argus Health
US Department of Justice

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078641

« Back to Dashboard
NDA 078641 describes FAMOTIDINE, which is a drug marketed by Perrigo, Sandoz, Mylan, Watson Labs, Hospira, Carlsbad, Apothecon, Fresenius Kabi Usa, Apotex, Ivax Sub Teva Pharms, Teva, Alembic Pharms Ltd, Dr Reddys Labs Ltd, Navinta Llc, Aurobindo Pharma Ltd, Wockhardt, Sun Pharm Inds, Lupin Ltd, Mylan Labs Ltd, Apotex Inc, Actavis Elizabeth, Athenex Inc, Perrigo R And D, Mylan Pharms Inc, Sun Pharm Inds Ltd, West-ward Pharms Int, Hi-tech Pharma Co, Novel Labs Inc, Abbvie, and Baxter Hlthcare, and is included in sixty-one NDAs. It is available from one hundred and twenty suppliers. Additional details are available on the FAMOTIDINE profile page.

The generic ingredient in FAMOTIDINE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and seventy drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for NDA: 078641

Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078641

Suppliers and Packaging for NDA: 078641

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 078641 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0125 0069-0125-02 10 VIAL, MULTI-DOSE in 1 CARTON (0069-0125-02) > 4 mL in 1 VIAL, MULTI-DOSE (0069-0125-01)
INJECTABLE;INJECTION 078641 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0126 0069-0126-02 10 VIAL, MULTI-DOSE in 1 CARTON (0069-0126-02) > 20 mL in 1 VIAL, MULTI-DOSE (0069-0126-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jun 25, 2008TE: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

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Federal Trade Commission
Argus Health

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
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

Google Plus