Ranitidine Hydrochloride

ANDA 75294, held by Dr Reddys Labs Ltd. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 75294 (Ranitidine Hydrochloride), held by Dr Reddys Labs Ltd, was first approved by FDA on Mar 28, 2000, with 18 approved supplements and 0 published complete response letters.

First approved: Mar 28, 2000
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Mar 28, 2000	Original application	Approved	Letter Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ranitidine HydrochlorideEQ 75MG BASE · tablet;oral	Ranitidine Hydrochloride	OTC

All 19 submissions, including labeling and manufacturing supplements


Feb 23, 2016	Supplement 32Labeling · Standard review	Approved	None posted
Feb 23, 2016	Supplement 31Labeling · Standard review	Approved	None posted
Apr 15, 2015	Supplement 30Manufacturing	Approved	None posted
Nov 1, 2010	Supplement 24Labeling	Approved	None posted
Aug 31, 2009	Supplement 22Labeling	Approved	None posted
Apr 6, 2009	Supplement 20Labeling	Approved	None posted
Mar 21, 2002	Supplement 12Labeling	Approved	None posted
Mar 16, 2001	Supplement 7Manufacturing	Approved	None posted
Mar 16, 2001	Supplement 6Labeling	Approved	None posted
Mar 16, 2001	Supplement 3Manufacturing	Approved	None posted
Mar 9, 2001	Supplement 11Manufacturing	Approved	None posted
Mar 9, 2001	Supplement 10Manufacturing	Approved	None posted
Mar 9, 2001	Supplement 9Labeling	Approved	None posted
Mar 9, 2001	Supplement 8Manufacturing	Approved	None posted
Nov 15, 2000	Supplement 5Manufacturing	Approved	None posted
Nov 15, 2000	Supplement 4Manufacturing	Approved	None posted
Aug 10, 2000	Supplement 2Manufacturing	Approved	None posted
Aug 10, 2000	Supplement 1Manufacturing	Approved	None posted
Mar 28, 2000	Original application	Approved	Letter Letter

Identifiers

Application: ANDA 75294
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters