Enablex

NDA 21513, held by Abbvie. Darifenacin Hydrobromide.

As of Nov 15, 2026, NDA 21513 (Enablex), held by Abbvie, was first approved by FDA on Dec 22, 2004, with 14 approved supplements and 0 published complete response letters.

First approved: Dec 22, 2004
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Dec 22, 2004	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


EnablexEQ 7.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Darifenacin Hydrobromide	DiscontinuedReference drug
EnablexEQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Darifenacin Hydrobromide	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Jul 14, 2021	Supplement 17Labeling · Standard review	Approved	Label Letter
Jan 13, 2016	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 18, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 5, 2013	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 20, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 9, 2013	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 3, 2013	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 15, 2012	Supplement 10Labeling · Standard review	Approved	Letter Label
Jan 13, 2012	Supplement 8Labeling · Standard review	Approved	Label Letter
Apr 18, 2011	Supplement 7Labeling	Approved	Letter Label
Oct 19, 2010	Supplement 6Labeling · Standard review	Approved	Letter Label
Dec 12, 2008	Supplement 5Labeling · Standard review	Approved	Label Letter
Apr 18, 2008	Supplement 4Labeling · Standard review	Approved	Label Letter
Oct 20, 2005	Supplement 2Manufacturing · Standard review	Approved	Letter Label
Dec 22, 2004	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21513
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