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Chinese Patent Office
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Harvard Business School
Medtronic
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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078884

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NDA 078884 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, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Silarx, 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 twenty-four 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 thirty-one suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 078884
Tradename:RANITIDINE HYDROCHLORIDE
Applicant:Wockhardt
Ingredient:ranitidine hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078884
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 078884 ANDA WOCKHARDT LIMITED 55648-740 N 55648-740-03
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 078884 ANDA WOCKHARDT LIMITED 55648-740 N 55648-740-04

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Jul 31, 2008TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Fuji
Chinese Patent Office
Cantor Fitzgerald
Citi
Accenture
US Army
Medtronic
Johnson and Johnson

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