Ranitidine Hydrochloride

ANDA 78542, held by Glenmark Pharms. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 78542 (Ranitidine Hydrochloride), held by Glenmark Pharms, was first approved by FDA on Nov 19, 2008, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 19, 2008
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Nov 19, 2008	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 3 submissions, including labeling and manufacturing supplements


Jul 31, 2011	Supplement 2Labeling	Approved	None posted
Apr 30, 2010	Supplement 1Labeling	Approved	None posted
Nov 19, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78542
Drugs@FDA: Overview at FDA
Company: Glenmark 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