Ranitidine Hydrochloride

ANDA 75000, held by Ranbaxy. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 75000 (Ranitidine Hydrochloride), held by Ranbaxy, was first approved by FDA on Jan 30, 1998, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 30, 1998
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jan 30, 1998	Original application	Approved	Review

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Aug 14, 2000	Supplement 2Labeling	Approved	None posted
Apr 22, 1999	Supplement 1Labeling	Approved	None posted
Jan 30, 1998	Original application	Approved	Review

Identifiers

Application: ANDA 75000
Drugs@FDA: Overview at FDA
Company: Ranbaxy Inc.

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