Ranitidine Hydrochloride

ANDA 75564, held by Rising. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 75564 (Ranitidine Hydrochloride), held by Rising, was first approved by FDA on Oct 27, 2000, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 27, 2000
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
Oct 27, 2000	Original application	Approved	Letter

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Dec 18, 2002	Supplement 3Manufacturing	Approved	None posted
Oct 27, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 75564
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