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Serving leading biopharmaceutical companies globally:

McKinsey
Healthtrust
Argus Health
McKesson
Baxter
Covington
Boehringer Ingelheim
Johnson and Johnson
Cipla
Mallinckrodt

Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076195

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NDA 076195 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, 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, Watson Labs, and Watson Labs Inc, and is included in sixty-three NDAs. It is available from one hundred and thirty-two 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-nine suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 076195

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 076195

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 076195 ANDA L. Perrigo Company 0113-0876 0113-0876-65 1 BOTTLE in 1 CARTON (0113-0876-65) > 30 TABLET, COATED in 1 BOTTLE
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 076195 ANDA Target Corporation 11673-876 11673-876-27 1 BOTTLE in 1 CARTON (11673-876-27) > 80 TABLET, COATED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Aug 30, 2002TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Cipla
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Dow
Merck
Farmers Insurance
Chinese Patent Office
Cantor Fitzgerald
Colorcon
Deloitte
Julphar

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