Ranitidine Hydrochloride

ANDA 76705, held by Dr Reddys Labs Inc. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 76705 (Ranitidine Hydrochloride), held by Dr Reddys Labs Inc, was first approved by FDA on Jul 27, 2005, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 27, 2005
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 27, 2005	Original application	Approved	None posted

Products

2 strengths and forms


Ranitidine HydrochlorideEQ 150MG BASE · tablet;oral	Ranitidine Hydrochloride	Rx
Ranitidine HydrochlorideEQ 300MG BASE · tablet;oral	Ranitidine Hydrochloride	Rx

All 4 submissions, including labeling and manufacturing supplements


Dec 28, 2009	Supplement 3Labeling	Approved	None posted
May 28, 2009	Supplement 2Labeling	Approved	None posted
Oct 30, 2007	Supplement 1Labeling	Approved	None posted
Jul 27, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76705
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