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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Mallinckrodt
Cerilliant
Moodys
Julphar
UBS
AstraZeneca
Medtronic

Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078653

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NDA 078653 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 078653
Tradename:RANITIDINE HYDROCHLORIDE
Applicant:Wockhardt
Ingredient:ranitidine hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078653
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 078653 ANDA L. Perrigo Company 0113-0047 N 0113-0047-02
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 078653 ANDA L. Perrigo Company 0113-0047 N 0113-0047-62

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Nov 26, 2007TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Citi
McKesson
Dow
Deloitte
UBS
Chubb
Cerilliant
Fuji

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