Last Updated: September 24, 2026

Details for New Drug Application (NDA): 091078

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NDA 091078 describes RANITIDINE HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Dr Reddys Labs Ltd, Novitium Pharma, Rising, 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, Sun Pharma Canada, Tolmar, Torrent, Wockhardt, Amneal Pharms Ny, Ani Pharms, Apotex, Boehringer Ingelheim, Contract Pharmacal, Dr Reddys Labs Inc, Glenmark Pharms, Granules, Heritage Pharma Avet, Mpp Pharma, Mylan, Perrigo, Perrigo R And D, Ph Health, Pharmobedient, 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 seven suppliers. Additional details are available on the RANITIDINE HYDROCHLORIDE profile page.

The generic ingredient in RANITIDINE HYDROCHLORIDE is ranitidine hydrochloride. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 091078

Tradename:	RANITIDINE HYDROCHLORIDE
Applicant:	Epic Pharma Llc
Ingredient:	ranitidine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	EQ 15MG BASE/ML
Approval Date:	Mar 22, 2011	TE:		RLD:	No

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