Ranitidine Hydrochloride

ANDA 75165, held by Heritage Pharma Avet. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 75165 (Ranitidine Hydrochloride), held by Heritage Pharma Avet, was first approved by FDA on Sep 30, 1998, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1998
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 30, 1998	Original application	Approved	Letter

Products

2 strengths and forms


Ranitidine HydrochlorideEQ 150MG BASE · tablet;oral	Ranitidine Hydrochloride	Discontinued
Ranitidine HydrochlorideEQ 300MG BASE · tablet;oral	Ranitidine Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Sep 2, 2010	Supplement 7Manufacturing	Approved	None posted
May 27, 2009	Supplement 5Labeling	Approved	None posted
Nov 23, 1999	Supplement 1Manufacturing	Approved	None posted
Sep 30, 1998	Original application	Approved	Letter

Identifiers

Application: ANDA 75165
Drugs@FDA: Overview at FDA
Company: Heritage Pharma Avet

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