Folic Acid

As of Nov 15, 2026, ANDA 84472 (Folic Acid), held by Sandoz, was first approved by FDA on Jun 16, 1976, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 16, 1976
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 16, 1976	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Folic Acid1MG · tablet;oral	Folic Acid	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Nov 16, 1988	Supplement 8Labeling	Approved	None posted
Oct 30, 1985	Supplement 4Manufacturing	Approved	None posted
Jul 12, 1983	Supplement 1Manufacturing	Approved	None posted
Jun 16, 1976	Original application	Approved	Review

Identifiers

Application: ANDA 84472
Drugs@FDA: Overview at FDA
Company: Sandoz

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