Ranitidine Hydrochloride

ANDA 74488, held by Ani Pharms. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 74488 (Ranitidine Hydrochloride), held by Ani Pharms, was first approved by FDA on Jul 31, 1997, with 19 approved supplements and 0 published complete response letters.

First approved: Jul 31, 1997
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jul 31, 1997	Original application	Approved	None posted

Products

2 strengths and forms


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

All 20 submissions, including labeling and manufacturing supplements


Aug 30, 2007	Supplement 22Labeling	Approved	None posted
Aug 1, 2003	Supplement 19Labeling	Approved	None posted
Mar 19, 2003	Supplement 17Labeling	Approved	None posted
Dec 13, 2001	Supplement 16Manufacturing	Approved	None posted
Dec 13, 2001	Supplement 15Manufacturing	Approved	None posted
Dec 13, 2001	Supplement 14Manufacturing	Approved	None posted
Dec 13, 2001	Supplement 13Manufacturing	Approved	None posted
May 22, 2001	Supplement 18Manufacturing	Approved	None posted
Sep 11, 2000	Supplement 12Labeling	Approved	None posted
Aug 30, 2000	Supplement 6Manufacturing	Approved	None posted
Aug 30, 2000	Supplement 5Labeling	Approved	None posted
Aug 30, 2000	Supplement 4Manufacturing	Approved	None posted
Aug 30, 2000	Supplement 3Manufacturing	Approved	None posted
Apr 6, 2000	Supplement 11Labeling	Approved	None posted
Apr 6, 2000	Supplement 10Labeling	Approved	None posted
Jul 14, 1999	Supplement 7Manufacturing	Approved	None posted
Jun 15, 1999	Supplement 2Manufacturing	Approved	None posted
Jun 7, 1999	Supplement 8Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 1Manufacturing	Approved	None posted
Jul 31, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74488
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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