Ranitidine Hydrochloride

ANDA 75094, held by Contract Pharmacal. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 75094 (Ranitidine Hydrochloride), held by Contract Pharmacal, was first approved by FDA on Jun 21, 1999, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 21, 1999
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 21, 1999	Original application	Approved	Letter

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Sep 21, 2000	Supplement 9Manufacturing	Approved	None posted
Jan 6, 2000	Supplement 1Manufacturing	Approved	None posted
Jun 21, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 75094
Drugs@FDA: Overview at FDA
Company: Contract Pharmacal Corporation

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