Ranitidine Hydrochloride

ANDA 91534, held by Zydus Pharms USA Inc. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 91534 (Ranitidine Hydrochloride), held by Zydus Pharms USA Inc, was first approved by FDA on Feb 22, 2013, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 22, 2013
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
Feb 22, 2013	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ranitidine HydrochlorideEQ 25MG BASE/ML · injectable;injection	Ranitidine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jul 17, 2013	Supplement 1Labeling · Standard review	Approved	None posted
Feb 22, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 91534
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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