Ranitidine Hydrochloride

ANDA 74864, held by Watson Labs. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 74864 (Ranitidine Hydrochloride), held by Watson Labs, was first approved by FDA on Oct 20, 1997, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 20, 1997
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Oct 20, 1997	Original application	Approved	None posted

Products

2 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Aug 30, 2007	Supplement 7Labeling	Approved	None posted
Dec 6, 2002	Supplement 5Labeling	Approved	None posted
Nov 3, 1999	Supplement 4Manufacturing	Approved	None posted
Nov 3, 1999	Supplement 3Manufacturing	Approved	None posted
Nov 3, 1999	Supplement 2Manufacturing	Approved	None posted
Aug 3, 1998	Supplement 1Manufacturing	Approved	None posted
Oct 20, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74864
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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