Ranitidine Hydrochloride

ANDA 78701, held by Wockhardt. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 78701 (Ranitidine Hydrochloride), held by Wockhardt, was first approved by FDA on Dec 11, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 11, 2009
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
Dec 11, 2009	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 2 submissions, including labeling and manufacturing supplements


Sep 7, 2010	Supplement 1Manufacturing	Approved	None posted
Dec 11, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78701
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