Ranitidine Hydrochloride

ANDA 74023, held by Mylan. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 74023 (Ranitidine Hydrochloride), held by Mylan, was first approved by FDA on Aug 22, 1997, with 12 approved supplements and 0 published complete response letters.

First approved: Aug 22, 1997
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Aug 22, 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 13 submissions, including labeling and manufacturing supplements


Nov 29, 2007	Supplement 23Labeling	Approved	None posted
Oct 31, 2006	Supplement 22Labeling	Approved	None posted
Oct 18, 2001	Supplement 14Manufacturing	Approved	None posted
Sep 29, 2000	Supplement 9Manufacturing	Approved	None posted
Jul 26, 2000	Supplement 8Manufacturing	Approved	None posted
Jan 6, 2000	Supplement 7Manufacturing	Approved	None posted
Aug 4, 1999	Supplement 5Manufacturing	Approved	None posted
Feb 16, 1999	Supplement 6Manufacturing	Approved	None posted
Aug 26, 1998	Supplement 1Manufacturing	Approved	None posted
Aug 26, 1998	Supplement 4Labeling	Approved	None posted
Mar 25, 1998	Supplement 2Manufacturing	Approved	None posted
Mar 25, 1998	Supplement 3Manufacturing	Approved	None posted
Aug 22, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74023
Drugs@FDA: Overview at FDA
Company: Mylan

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