Ranitidine Hydrochloride

ANDA 75296, held by Ani Pharms. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 75296 (Ranitidine Hydrochloride), held by Ani Pharms, was first approved by FDA on Jan 14, 2000, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 14, 2000
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jan 14, 2000	Original application	Approved	Letter

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Aug 20, 2002	Supplement 7Labeling	Approved	None posted
Oct 18, 2001	Supplement 6Manufacturing	Approved	None posted
Sep 7, 2000	Supplement 4Manufacturing	Approved	None posted
Sep 7, 2000	Supplement 5Manufacturing	Approved	None posted
Jul 26, 2000	Supplement 1Manufacturing	Approved	None posted
Jul 26, 2000	Supplement 2Manufacturing	Approved	None posted
Jul 26, 2000	Supplement 3Labeling	Approved	None posted
Jan 14, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 75296
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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