Ranitidine Hydrochloride

ANDA 90102, held by Torrent. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 90102 (Ranitidine Hydrochloride), held by Torrent, was first approved by FDA on May 26, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: May 26, 2009
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 26, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ranitidine HydrochlorideEQ 15MG BASE/ML · syrup;oral	Ranitidine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Apr 30, 2010	Supplement 2Labeling	Approved	None posted
May 26, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90102
Drugs@FDA: Overview at FDA
Company: Torrent Pharmaceuticals

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