Ranitidine Hydrochloride

ANDA 75180, held by Ph Health. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 75180 (Ranitidine Hydrochloride), held by Ph Health, was first approved by FDA on Jan 28, 1999, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 28, 1999
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jan 28, 1999	Original application	Approved	Letter

Products

2 strengths and forms


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

All 6 submissions, including labeling and manufacturing supplements


Sep 6, 2007	Supplement 14Labeling	Approved	None posted
Oct 31, 2006	Supplement 11Labeling	Approved	None posted
Apr 4, 2003	Supplement 5Labeling	Approved	None posted
Jul 15, 2002	Supplement 6Manufacturing	Approved	None posted
Jan 18, 2001	Supplement 1Labeling	Approved	None posted
Jan 28, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 75180
Drugs@FDA: Overview at FDA
Company: PH Health

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