Ranitidine Hydrochloride

ANDA 78884, held by Wockhardt. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 78884 (Ranitidine Hydrochloride), held by Wockhardt, was first approved by FDA on Jul 31, 2008, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 31, 2008
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
Jul 31, 2008	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ranitidine HydrochlorideEQ 75MG BASE · tablet;oral	Ranitidine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Dec 11, 2014	Supplement 3Labeling	Approved	None posted
Jul 31, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78884
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