Orange Book product · Brand (NDA)
ENABLEX
DARIFENACIN HYDROBROMIDE
At a glance
Dec 22, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 2004
21 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DARIFENACIN HYDROBROMIDE
Strength
EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021513
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2020DARIFENACIN HYDROBROMIDEGeneric (ANDA)
ANDA 211045 · PURACAP LABS BLU
- 2019DARIFENACIN HYDROBROMIDEGeneric (ANDA)
ANDA 209571 · XIROMED
- 2017DARIFENACIN HYDROBROMIDEGeneric (ANDA)
ANDA 207681 · ALEMBIC
- 2017DARIFENACINGeneric (ANDA)
ANDA 207302 · MACLEODS PHARMS LTD
- 2016DARIFENACIN HYDROBROMIDEGeneric (ANDA)
ANDA 205209 · TORRENT
- 2016DARIFENACIN HYDROBROMIDEGeneric (ANDA)
ANDA 205550 · JUBILANT GENERICS
- 2016DARIFENACIN HYDROBROMIDEGeneric (ANDA)
ANDA 206743 · AUROBINDO PHARMA
- 2016DARIFENACIN HYDROBROMIDEGeneric (ANDA)
ANDA 207664 · CIPLA
- 2015DARIFENACIN HYDROBROMIDEGeneric (ANDA)
ANDA 091190 · PH HEALTH
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
