Ranitidine Hydrochloride

ANDA 75167, held by Apotex. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 75167 (Ranitidine Hydrochloride), held by Apotex, was first approved by FDA on May 4, 2000, with 3 approved supplements and 0 published complete response letters.

First approved: May 4, 2000
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
May 4, 2000	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ranitidine HydrochlorideEQ 75MG BASE · tablet;oral	Ranitidine Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Oct 3, 2018	Supplement 13Labeling · Standard review	Approved	None posted
Jun 21, 2002	Supplement 2Labeling	Approved	None posted
Aug 31, 2001	Supplement 1Manufacturing	Approved	None posted
May 4, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 75167
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