Famotidine

ANDA 215822, held by Vkt Pharma. Famotidine.

As of Nov 15, 2026, ANDA 215822 (Famotidine), held by Vkt Pharma, was first approved by FDA on Jan 28, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 28, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use(s) relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 28, 2022	Original application	Approved	None posted

Products

2 strengths and forms


Famotidine10MG · tablet;oral	Famotidine	OTC
Famotidine20MG · tablet;oral	Famotidine	OTC

All 2 submissions, including labeling and manufacturing supplements


Jul 28, 2022	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 28, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 215822
Drugs@FDA: Overview at FDA
Company: VKT 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