Ranitidine Hydrochloride

ANDA 200536, held by Strides Pharma. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 200536 (Ranitidine Hydrochloride), held by Strides Pharma, was first approved by FDA on Jun 28, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 28, 2011
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
Jun 28, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ranitidine HydrochlorideEQ 150MG BASE · tablet;oral	Ranitidine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Dec 11, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Jun 28, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 200536
Drugs@FDA: Overview at FDA
Company: Strides Pharma Inc

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