Ranitidine Hydrochloride

ANDA 74777, held by Hikma. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 74777 (Ranitidine Hydrochloride), held by Hikma, was first approved by FDA on Mar 2, 2005, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 2, 2005
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
Mar 2, 2005	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ranitidine HydrochlorideEQ 25MG BASE/ML · injectable;injection	Ranitidine Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jan 28, 2010	Supplement 5Labeling	Approved	None posted
Jun 18, 2009	Supplement 4Labeling	Approved	None posted
Feb 15, 2006	Supplement 2Labeling	Approved	None posted
Mar 2, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 74777
Drugs@FDA: Overview at FDA
Company: Hikma

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