Ranitidine Hydrochloride

ANDA 75497, held by Rising. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 75497 (Ranitidine Hydrochloride), held by Rising, was first approved by FDA on Jan 14, 2000, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 14, 2000
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
Jan 14, 2000	Original application	Approved	Letter

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Apr 18, 2003	Supplement 3Labeling	Approved	None posted
Oct 16, 2001	Supplement 2Manufacturing	Approved	None posted
Oct 26, 2000	Supplement 1Manufacturing	Approved	None posted
Jan 14, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 75497
Drugs@FDA: Overview at FDA
Company: Rising 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