Folic Acid

ANDA 81066, held by Ben Venue. Folic Acid.

As of Nov 15, 2026, ANDA 81066 (Folic Acid), held by Ben Venue, was first approved by FDA on Dec 29, 1993, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 29, 1993
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 29, 1993	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Apr 3, 2001	Supplement 2Manufacturing	Approved	None posted
Dec 29, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 81066
Drugs@FDA: Overview at FDA
Company: Ben Venue Laboratories

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