Famotidine Preservative Free

ANDA 76324, held by Epic Pharma LLC. Famotidine.

As of Nov 15, 2026, ANDA 76324 (Famotidine Preservative Free), held by Epic Pharma LLC, was first approved by FDA on Nov 27, 2002, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 27, 2002
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
Nov 27, 2002	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Famotidine Preservative Free10MG/ML · injectable;injection	Famotidine	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 25, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Nov 27, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 76324
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