Ranitidine Hydrochloride

ANDA 75208, held by Wockhardt Ltd. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 75208 (Ranitidine Hydrochloride), held by Wockhardt Ltd, was first approved by FDA on Dec 17, 1998, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 17, 1998
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 17, 1998	Original application	Approved	Letter

Products

2 strengths and forms


Ranitidine HydrochlorideEQ 150MG BASE · tablet;oral	Ranitidine Hydrochloride	Discontinued
Ranitidine HydrochlorideEQ 300MG BASE · tablet;oral	Ranitidine Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jan 18, 2005	Supplement 7Labeling	Approved	None posted
Apr 9, 2002	Supplement 4Manufacturing	Approved	None posted
Apr 9, 2002	Supplement 3Manufacturing	Approved	None posted
Apr 9, 2002	Supplement 2Manufacturing	Approved	None posted
Dec 17, 1998	Original application	Approved	Letter

Identifiers

Application: ANDA 75208
Drugs@FDA: Overview at FDA
Company: Wockhardt

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