Folic Acid

ANDA 202437, held by Cadila Pharms Ltd. Folic Acid.

As of Nov 15, 2026, ANDA 202437 (Folic Acid), held by Cadila Pharms Ltd, was first approved by FDA on Jan 27, 2014, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 27, 2014
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE Folic acid, USP 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
Jan 27, 2014	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


Oct 9, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Jan 27, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 202437
Drugs@FDA: Overview at FDA
Company: Cadila Pharmaceuticals

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