Ranitidine Hydrochloride

ANDA 205512, held by Strides Pharma. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 205512 (Ranitidine Hydrochloride), held by Strides Pharma, was first approved by FDA on Aug 22, 2016, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 22, 2016
Review: Standard
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
Aug 22, 2016	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Mar 22, 2019	Supplement 8Manufacturing	Approved	None posted
Aug 22, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 205512
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