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Generated: September 19, 2018

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Details for New Drug Application (NDA): 200172

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NDA 200172 describes RANITIDINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, 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, 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, Granules India Ltd, 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-nine NDAs. It is available from one hundred and thirty-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 forty-two suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 200172
Tradename:RANITIDINE HYDROCHLORIDE
Applicant:Apotex Inc
Ingredient:ranitidine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200172
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 200172 ANDA Walgreens Company 0363-1030 0363-1030-01 1 BOTTLE in 1 CARTON (0363-1030-01) > 65 TABLET in 1 BOTTLE
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 200172 ANDA Walgreens Company 0363-1030 0363-1030-02 1 BOTTLE in 1 CARTON (0363-1030-02) > 24 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:May 31, 2012TE:RLD:No

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