Ranitidine Hydrochloride

ANDA 91078, held by Epic Pharma LLC. Ranitidine Hydrochloride.

As of Nov 15, 2026, ANDA 91078 (Ranitidine Hydrochloride), held by Epic Pharma LLC, was first approved by FDA on Mar 22, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 22, 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
Mar 22, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ranitidine HydrochlorideEQ 15MG BASE/ML · syrup;oral	Ranitidine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jul 12, 2012	Supplement 2Manufacturing	Approved	None posted
Mar 22, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91078
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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