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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 077405

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NDA 077405 describes RANITIDINE HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Dr Reddys Labs Ltd, Novitium Pharma, Pharmobedient, 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 Inc, Granules, Heritage Pharma Avet, Mpp Pharma, Mylan, Perrigo, Perrigo R And D, Ph Health, 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 eight 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. Eight suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 077405

Tradename:	RANITIDINE HYDROCHLORIDE
Applicant:	Pharm Assoc
Ingredient:	ranitidine hydrochloride
Patents:	0

Pharmacology for NDA: 077405

Mechanism of Action	Histamine H2 Receptor Antagonists

Suppliers and Packaging for NDA: 077405

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	SYRUP;ORAL	077405	ANDA	Pharmaceutical Associates, Inc.	0121-0727	0121-0727-16	473 mL in 1 BOTTLE (0121-0727-16)
RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	SYRUP;ORAL	077405	ANDA	Pharmaceutical Associates, Inc.	0121-4727	0121-4727-10	4 TRAY in 1 CASE (0121-4727-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	EQ 15MG BASE/ML
Approval Date:	Sep 21, 2007	TE:		RLD:	No

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