Ranitidine Hydrochloride

ANDA 75132, held by Sun Pharm Inds Ltd. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 75132 (Ranitidine Hydrochloride), held by Sun Pharm Inds Ltd, was first approved by FDA on Jan 14, 2000, with 13 approved supplements and 0 published complete response letters.

First approved: Jan 14, 2000
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 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 14 submissions, including labeling and manufacturing supplements


Feb 29, 2008	Supplement 20Labeling	Approved	None posted
May 23, 2003	Supplement 11Labeling	Approved	None posted
Oct 3, 2002	Supplement 12Manufacturing	Approved	None posted
May 20, 2002	Supplement 10Manufacturing	Approved	None posted
Apr 4, 2001	Supplement 9Manufacturing	Approved	None posted
Nov 28, 2000	Supplement 8Manufacturing	Approved	None posted
Nov 28, 2000	Supplement 7Manufacturing	Approved	None posted
Nov 28, 2000	Supplement 6Manufacturing	Approved	None posted
Jun 29, 2000	Supplement 5Labeling	Approved	None posted
Jun 29, 2000	Supplement 4Manufacturing	Approved	None posted
Jun 29, 2000	Supplement 3Manufacturing	Approved	None posted
Jun 29, 2000	Supplement 2Manufacturing	Approved	None posted
Jun 29, 2000	Supplement 1Manufacturing	Approved	None posted
Jan 14, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 75132
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