Folic Acid

ANDA 89202, held by Fresenius Kabi USA. Folic Acid.

As of Nov 15, 2026, ANDA 89202 (Folic Acid), held by Fresenius Kabi USA, was first approved by FDA on Feb 18, 1986, with 9 approved supplements and 0 published complete response letters.

First approved: Feb 18, 1986
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: Folic Acid Injection, USP alone is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid as may be seen in tropical or nontropical sprue, in anemias of nutritional origin, pregnancy, infancy or childhood.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Feb 18, 1986	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Folic Acid5MG/ML · injectable;injection	Folic Acid	Rx

All 10 submissions, including labeling and manufacturing supplements


Aug 11, 2006	Supplement 20Labeling	Approved	None posted
Mar 21, 2006	Supplement 15Labeling	Approved	None posted
Dec 5, 2002	Supplement 10Manufacturing	Approved	None posted
Jan 20, 1995	Supplement 8Manufacturing	Approved	None posted
Jul 6, 1990	Supplement 7Manufacturing	Approved	None posted
Dec 8, 1988	Supplement 3Manufacturing	Approved	None posted
Dec 8, 1988	Supplement 4Manufacturing	Approved	None posted
Dec 8, 1988	Supplement 5Manufacturing	Approved	None posted
Dec 8, 1988	Supplement 6Manufacturing	Approved	None posted
Feb 18, 1986	Original application	Approved	Review

Identifiers

Application: ANDA 89202
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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