Ranitidine Hydrochloride

ANDA 200172, held by Apotex Inc. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 200172 (Ranitidine Hydrochloride), held by Apotex Inc, was first approved by FDA on May 31, 2012, with 1 approved supplement and 0 published complete response letters.

First approved: May 31, 2012
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 31, 2012	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ranitidine HydrochlorideEQ 150MG BASE · tablet;oral	Ranitidine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Nov 14, 2016	Supplement 5Labeling · Standard review	Approved	None posted
May 31, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 200172
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