Ranitidine Hydrochloride

ANDA 77405, held by Pharm Assoc. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 77405 (Ranitidine Hydrochloride), held by Pharm Assoc, was first approved by FDA on Sep 21, 2007, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 21, 2007
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 21, 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 4 submissions, including labeling and manufacturing supplements


Oct 27, 2010	Supplement 4Labeling	Approved	None posted
Jan 31, 2010	Supplement 3Labeling	Approved	None posted
May 28, 2009	Supplement 1Labeling	Approved	None posted
Sep 21, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77405
Drugs@FDA: Overview at FDA
Company: Pharmaceutical Associates

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