Vaniqa

NDA 21145, held by Abbvie. Eflornithine Hydrochloride.

As of Nov 14, 2026, NDA 21145 (Vaniqa), held by Abbvie, was first approved by FDA on Jul 27, 2000, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 27, 2000
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jul 27, 2000	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vaniqa13.9% · cream;topical	Eflornithine Hydrochloride	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements


Feb 29, 2016	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 30, 2013	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 22, 2013	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 5, 2001	Supplement 5Manufacturing · Standard review	Approved	Review
Jun 29, 2001	Supplement 3Manufacturing · Standard review	Approved	Review
Jun 25, 2001	Supplement 2Manufacturing · Standard review	Approved	Review
Dec 15, 2000	Supplement 1Manufacturing · Standard review	Approved	Review
Jul 27, 2000	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21145
Drugs@FDA: Overview at FDA
Company: AbbVie

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