Application 021513

Type: NDA
Sponsor: APIL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENABLEX	DARIFENACIN HYDROBROMIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 7.5MG BASE	Yes	No
002	ENABLEX	DARIFENACIN HYDROBROMIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 15MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021513-001	ENABLEX	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-12-22
N021513-002	ENABLEX	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-12-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021513-001	ENABLEX	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-12-22	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021513-002	ENABLEX	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021513-001	ENABLEX	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-12-22	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021513-002	ENABLEX	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021513-001	ENABLEX	EQ 7.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-12-22	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021513-002	ENABLEX	EQ 15MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-12-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021513-001	ENABLEX	EQ 7.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-12-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021513-002	ENABLEX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-12-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021513-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021513-002	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021513-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021513-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021513-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021513-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021513-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021513-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021513-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021513-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021513-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021513-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021513-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021513-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021513-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021513-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021513-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021513-002	AB	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Darifenacin	DARIFENACIN HYDROBROMIDE	Cipla USA Inc.	6e8470d1-c3e6-4644-b70a-aa47ddf79676	2025-10-27	Warnings, Adverse reactions	Name fallback generic name: DARIFENACIN HYDROBROMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0430-0170	Enablex	darifenacin	Allergan, Inc.	NDA	Current
0430-0170	Enablex	darifenacin	Allergan, Inc.	NDA	Current
0430-0170	Enablex	darifenacin	Allergan, Inc.	NDA	Current
0430-0170	Enablex	darifenacin	Allergan, Inc.	NDA	Current
0430-0171	Enablex	darifenacin	Allergan, Inc.	NDA	Current
0430-0171	Enablex	darifenacin	Allergan, Inc.	NDA	Current
0430-0171	Enablex	darifenacin	Allergan, Inc.	NDA	Current
0430-0171	Enablex	darifenacin	Allergan, Inc.	NDA	Current
0591-4375	Darifenacin	darifenacin	Actavis Pharma, Inc.	NDA	Current
0591-4375	Darifenacin	darifenacin	Actavis Pharma, Inc.	NDA	Current
0591-4380	Darifenacin	darifenacin	Actavis Pharma, Inc.	NDA	Current
0591-4380	Darifenacin	darifenacin	Actavis Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68106	SUPPL	2021-07-16
68092	SUPPL	2021-07-15
5591	SUPPL	2012-03-19
15644	SUPPL	2012-03-16
15643	SUPPL	2012-01-26
27984	SUPPL	2012-01-18
27983	SUPPL	2011-04-20
15642	SUPPL	2011-04-18
27982	SUPPL	2010-10-25
37111	SUPPL	2010-10-19
37110	SUPPL	2009-01-02
5590	SUPPL	2008-12-19
15641	SUPPL	2008-06-05
5589	SUPPL	2008-04-22
15640	SUPPL	2005-10-25
5588	SUPPL	2005-10-25
21707	ORIG	2005-02-08
15639	ORIG	2004-12-29
5587	ORIG	2004-12-29