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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 209859

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NDA 209859 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 209859

Tradename:	RANITIDINE HYDROCHLORIDE
Applicant:	Ajanta Pharma Ltd
Ingredient:	ranitidine hydrochloride
Patents:	0

Pharmacology for NDA: 209859

Mechanism of Action	Histamine H2 Receptor Antagonists

Suppliers and Packaging for NDA: 209859

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	CAPSULE;ORAL	209859	ANDA	Ajanta Pharma USA Inc.	27241-109	27241-109-06	60 CAPSULE in 1 BOTTLE (27241-109-06)
RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	CAPSULE;ORAL	209859	ANDA	Ajanta Pharma USA Inc.	27241-109	27241-109-50	500 CAPSULE in 1 BOTTLE (27241-109-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Sep 27, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 300MG BASE
Approval Date:	Sep 27, 2018	TE:		RLD:	No

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