Ranitidine Hydrochloride

ANDA 74680, held by Apotex. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 74680 (Ranitidine Hydrochloride), held by Apotex, was first approved by FDA on Sep 12, 1997, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 12, 1997
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Sep 12, 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 6 submissions, including labeling and manufacturing supplements


Jun 18, 2012	Supplement 16Labeling	Approved	None posted
Dec 23, 2005	Supplement 13Labeling	Approved	None posted
May 1, 2000	Supplement 2Manufacturing	Approved	None posted
May 1, 2000	Supplement 3Manufacturing	Approved	None posted
Mar 24, 1999	Supplement 1Manufacturing	Approved	None posted
Sep 12, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74680
Drugs@FDA: Overview at FDA
Company: Apotex

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