Ranitidine Hydrochloride

ANDA 75439, held by Sun Pharm Inds Ltd. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 75439 (Ranitidine Hydrochloride), held by Sun Pharm Inds Ltd, was first approved by FDA on Apr 19, 2000, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 19, 2000
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
Apr 19, 2000	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 7 submissions, including labeling and manufacturing supplements


Oct 3, 2002	Supplement 7Manufacturing	Approved	None posted
Oct 1, 2002	Supplement 6Manufacturing	Approved	None posted
Apr 4, 2001	Supplement 5Manufacturing	Approved	None posted
Nov 9, 2000	Supplement 2Manufacturing	Approved	None posted
Nov 9, 2000	Supplement 3Manufacturing	Approved	None posted
Nov 9, 2000	Supplement 4Manufacturing	Approved	None posted
Apr 19, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 75439
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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