Ranitidine Hydrochloride

ANDA 76195, held by Perrigo. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 76195 (Ranitidine Hydrochloride), held by Perrigo, was first approved by FDA on Aug 30, 2002, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 30, 2002
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 30, 2002	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ranitidine HydrochlorideEQ 75MG BASE · tablet;oral	Ranitidine Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Oct 4, 2023	Supplement 31Labeling · Standard review	Approved	None posted
Oct 4, 2023	Supplement 32Labeling · Standard review	Approved	None posted
Jan 24, 2018	Supplement 30Manufacturing	Approved	None posted
Feb 5, 2016	Supplement 23Manufacturing	Approved	None posted
Aug 30, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 76195
Drugs@FDA: Overview at FDA
Company: Perrigo

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