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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091429

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NDA 091429 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-five 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 091429
Tradename:RANITIDINE HYDROCHLORIDE
Applicant:Perrigo R And D
Ingredient:ranitidine hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 091429
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 091429 ANDA L. Perrigo Company 0113-0852 0113-0852-62 24 BLISTER PACK in 1 CARTON (0113-0852-62) > 1 TABLET, FILM COATED in 1 BLISTER PACK
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 091429 ANDA L. Perrigo Company 0113-0852 0113-0852-51 8 BLISTER PACK in 1 CARTON (0113-0852-51) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:May 11, 2011TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:May 11, 2011TE:RLD:No

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