Ranitidine Hydrochloride

ANDA 77426, held by Ani Pharms. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 77426 (Ranitidine Hydrochloride), held by Ani Pharms, was first approved by FDA on Dec 19, 2005, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 19, 2005
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
Dec 19, 2005	Original application	Approved	None posted

Products

2 strengths and forms


Ranitidine HydrochlorideEQ 150MG BASE · tablet;oral	Ranitidine Hydrochloride	Discontinued
Ranitidine HydrochlorideEQ 300MG BASE · tablet;oral	Ranitidine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Oct 30, 2007	Supplement 1Labeling	Approved	None posted
Dec 19, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77426
Drugs@FDA: Overview at FDA
Company: ANI 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