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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Express Scripts
Harvard Business School
Baxter
Queensland Health
Cantor Fitzgerald
UBS
Accenture
Dow

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074680

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NDA 074680 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 074680
Tradename:RANITIDINE HYDROCHLORIDE
Applicant:Apotex
Ingredient:ranitidine hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074680
Suppliers and Packaging for NDA: 074680
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 074680 ANDA State of Florida DOH Central Pharmacy 53808-0731 E 53808-0731-1
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 074680 ANDA Apotex Corp 60505-0025 E 60505-0025-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Sep 12, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Sep 12, 1997TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Merck
Teva
Colorcon
Julphar
Chubb
Healthtrust
Dow
Chinese Patent Office

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