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Last Updated: March 14, 2025

Details for New Drug Application (NDA): 078192

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NDA 078192 describes RANITIDINE HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Dr Reddys Labs Ltd, Norvium Bioscience, Novitium Pharma, Sandoz, Teva, Bedford, Hikma, Mylan Labs Ltd, Zydus Pharms Usa Inc, Actavis Mid Atlantic, Amneal Pharms, Apotex Inc, Epic Pharma Llc, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Taro, Tolmar, Torrent, Wockhardt, Amneal Pharms Ny, Ani Pharms, Apotex, Boehringer Ingelheim, Contract Pharmacal, Dr Reddys Labs Inc, Endo Operations, Glenmark Pharms Inc, Granules, Heritage Pharma Avet, Mylan, Perrigo, Perrigo R And D, Strides Pharma, Sun Pharm Inds Ltd, Thinq Pharm-cro Pvt, Vkt Pharma, Watson Labs, and Wockhardt Ltd, and is included in seventy-five NDAs. It is available from eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 078192

Tradename:	RANITIDINE HYDROCHLORIDE
Applicant:	Dr Reddys Labs Ltd
Ingredient:	ranitidine hydrochloride
Patents:	0

Pharmacology for NDA: 078192

Mechanism of Action	Histamine H2 Receptor Antagonists

Suppliers and Packaging for NDA: 078192

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	078192	ANDA	Dr. Reddy's Laboratories Limited	55111-404	55111-404-02	1 BOTTLE in 1 CARTON (55111-404-02) / 200 TABLET, COATED in 1 BOTTLE
RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	078192	ANDA	Dr. Reddy's Laboratories Limited	55111-404	55111-404-17	1 BLISTER PACK in 1 CARTON (55111-404-17) / 8 TABLET, COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	Aug 31, 2007	TE:		RLD:	No

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