Folic Acid

ANDA 85061, held by Contract Pharmacal. Folic Acid.

As of Nov 15, 2026, ANDA 85061 (Folic Acid), held by Contract Pharmacal, was first approved by FDA on Jul 29, 1976, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 29, 1976
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 29, 1976	Original application	Approved	Review

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Mar 5, 1986	Supplement 11Manufacturing	Approved	None posted
Jul 23, 1985	Supplement 10Manufacturing	Approved	None posted
May 15, 1985	Supplement 9Manufacturing	Approved	None posted
May 15, 1985	Supplement 7Manufacturing	Approved	None posted
May 15, 1985	Supplement 6Manufacturing	Approved	None posted
Jul 29, 1976	Original application	Approved	Review

Identifiers

Application: ANDA 85061
Drugs@FDA: Overview at FDA
Company: Contract Pharmacal Corporation

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