Ranitidine Hydrochloride

ANDA 78653, held by Wockhardt. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 78653 (Ranitidine Hydrochloride), held by Wockhardt, was first approved by FDA on Nov 26, 2007, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 26, 2007
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
Nov 26, 2007	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


Jan 12, 2015	Supplement 3Labeling	Approved	None posted
Nov 26, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78653
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