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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Cipla
Fuji
Cantor Fitzgerald
Express Scripts
McKesson
QuintilesIMS
AstraZeneca
Boehringer Ingelheim

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077824

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NDA 077824 describes RANITIDINE HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Ltd, Mylan, Sandoz, Teva, Bedford, Mylan Labs Ltd, West-ward Pharms Int, Zydus Pharms Usa Inc, Actavis Mid Atlantic, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bio Pharm Inc, Breckenridge Pharm, Hi Tech Pharma, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Taro, Tolmar, Wockhardt, Acic Pharms, Amneal Pharms Ny, Apotex, Boehringer Ingelheim, Contract Pharmacal, Dr Reddys Labs Inc, Glenmark Pharms Inc, Ivax Sub Teva Pharms, Par Pharm, Perrigo, Perrigo R And D, Strides Pharma, Sun Pharm Inds Ltd, Vivimed Global, Watson Labs, Watson Labs Inc, and Wockhardt Ltd, and is included in sixty-six NDAs. It is available from one hundred and thirty-seven suppliers. Additional details are available on the RANITIDINE HYDROCHLORIDE profile page.

The generic ingredient in RANITIDINE HYDROCHLORIDE is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. One hundred and forty-five suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 077824
Tradename:RANITIDINE HYDROCHLORIDE
Applicant:Amneal Pharms Ny
Ingredient:ranitidine hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077824
Suppliers and Packaging for NDA: 077824
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 077824 ANDA Liberty Pharmaceuticals, Inc. 0440-8300 N 0440-8300-60
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 077824 ANDA Liberty Pharmaceuticals, Inc. 0440-8305 N 0440-8305-00

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Oct 13, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Oct 13, 2006TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Johnson and Johnson
Harvard Business School
US Army
Medtronic
Express Scripts
Farmers Insurance
Argus Health

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