Ranitidine Hydrochloride

ANDA 74467, held by Sandoz. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 74467 (Ranitidine Hydrochloride), held by Sandoz, was first approved by FDA on Aug 29, 1997, with 25 approved supplements and 0 published complete response letters.

First approved: Aug 29, 1997
Supplements approved: 25
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Aug 29, 1997	Original application	Approved	Review Review

Products

2 strengths and forms


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

All 26 submissions, including labeling and manufacturing supplements


Feb 7, 2013	Supplement 36Labeling	Approved	None posted
May 27, 2009	Supplement 35Labeling	Approved	None posted
Dec 26, 2007	Supplement 30Labeling	Approved	None posted
Apr 28, 2005	Supplement 28Labeling	Approved	None posted
Nov 5, 2002	Supplement 25Manufacturing	Approved	None posted
Apr 19, 2002	Supplement 23Manufacturing	Approved	None posted
Feb 27, 2001	Supplement 22Manufacturing	Approved	None posted
Dec 7, 2000	Supplement 18Manufacturing	Approved	None posted
Dec 7, 2000	Supplement 17Manufacturing	Approved	None posted
Nov 30, 2000	Supplement 21Manufacturing	Approved	None posted
Nov 30, 2000	Supplement 20Labeling	Approved	None posted
Nov 30, 2000	Supplement 19Manufacturing	Approved	None posted
Nov 9, 2000	Supplement 14Manufacturing	Approved	None posted
May 25, 2000	Supplement 16Labeling	Approved	None posted
Mar 8, 2000	Supplement 15Labeling	Approved	None posted
Aug 18, 1999	Supplement 9Manufacturing	Approved	None posted
Aug 18, 1999	Supplement 8Manufacturing	Approved	None posted
Aug 18, 1999	Supplement 7Manufacturing	Approved	None posted
Aug 18, 1999	Supplement 6Manufacturing	Approved	None posted
Jun 18, 1999	Supplement 11Manufacturing	Approved	None posted
Apr 23, 1999	Supplement 5Labeling	Approved	None posted
Apr 23, 1999	Supplement 4Manufacturing	Approved	None posted
Dec 8, 1998	Supplement 3Manufacturing	Approved	None posted
Feb 17, 1998	Supplement 2Manufacturing	Approved	None posted
Feb 17, 1998	Supplement 1Manufacturing	Approved	None posted
Aug 29, 1997	Original application	Approved	Review Review

Identifiers

Application: ANDA 74467
Drugs@FDA: Overview at FDA
Company: Sandoz

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