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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Teva
Cerilliant
Chinese Patent Office
Covington
Chubb
Fuji
Medtronic
McKinsey
Argus Health

Generated: July 20, 2017

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Details for New Drug Application (NDA): 200536

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NDA 200536 describes RANITIDINE HYDROCHLORIDE, which is a drug marketed by Ranbaxy, Wockhardt, Apotex Inc, Bio Pharm Inc, Pharm Assoc, Dr Reddys Labs Inc, Amneal Pharms, Strides Pharma, Watson Labs, Sandoz, Aurobindo Pharma Ltd, Mylan, Actavis Mid Atlantic, Amneal Pharms Ny, Watson Labs Inc, Perrigo R And D, Sun Pharm Inds Ltd, Zydus Pharms Usa Inc, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Tolmar, Teva, West-ward Pharms Int, Boehringer Ingelheim, Bedford, Ivax Sub Teva Pharms, Mylan Labs Ltd, Taro, Hi Tech Pharma, Apotex, Par Pharm, Breckenridge Pharm, Silarx, Vintage Pharms, Nostrum Labs Inc, Contract Pharmacal, and Perrigo, and is included in sixty-one 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 forty suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for NDA: 200536

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

Suppliers and Packaging for NDA: 200536

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride
TABLET;ORAL 200536 ANDA Walgreen Company 0363-0362 0363-0362-02 1 BOTTLE in 1 CARTON (0363-0362-02) > 200 TABLET in 1 BOTTLE
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride
TABLET;ORAL 200536 ANDA Walgreen Company 0363-0362 0363-0362-23 1 BOTTLE in 1 CARTON (0363-0362-23) > 24 TABLET in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Jun 28, 2011TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
US Department of Justice
UBS
Medtronic
Accenture
Cipla
Cerilliant
Covington
Harvard Business School
Cantor Fitzgerald

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