Ranitidine Hydrochloride

ANDA 77602, held by Apotex Inc. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 77602 (Ranitidine Hydrochloride), held by Apotex Inc, was first approved by FDA on Sep 17, 2007, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 17, 2007
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
Sep 17, 2007	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


Oct 27, 2010	Supplement 5Labeling	Approved	None posted
Sep 17, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77602
Drugs@FDA: Overview at FDA
Company: Apotex

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