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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Cipla
Dow
Cantor Fitzgerald
McKinsey
Merck
Covington
AstraZeneca

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075742

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NDA 075742 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, Vintage Pharms, 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-five 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-three suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 075742
Tradename:RANITIDINE HYDROCHLORIDE
Applicant:Dr Reddys Labs Ltd
Ingredient:ranitidine hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075742
Suppliers and Packaging for NDA: 075742
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride CAPSULE;ORAL 075742 ANDA AvKARE, Inc. 42291-735 N 42291-735-50
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride CAPSULE;ORAL 075742 ANDA AvKARE, Inc. 42291-736 N 42291-736-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Nov 29, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 300MG BASE
Approval Date:Nov 29, 2000TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Dow
Queensland Health
Medtronic
Harvard Business School
Citi
Boehringer Ingelheim
Argus Health
Deloitte

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