Folic Acid

ANDA 90035, held by Chartwell Molecular. Folic Acid.

As of Nov 15, 2026, ANDA 90035 (Folic Acid), held by Chartwell Molecular, was first approved by FDA on Jun 9, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 9, 2009
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and 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 2 submissions below

Date	Submission	Status	Documents
Jun 9, 2009	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Aug 13, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Jun 9, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90035
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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