Orange Book product · Generic (ANDA)
DARIFENACIN HYDROBROMIDE
DARIFENACIN HYDROBROMIDE
At a glance
Oct 22, 2019
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 22, 2019
6 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
DARIFENACIN HYDROBROMIDE
Strength
EQ 7.5MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 209571
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DARIFENACIN HYDROBROMIDE
- 2004ENABLEXBrand (NDA)
NDA 021513 · ABBVIE
- 2020DARIFENACIN HYDROBROMIDEGeneric (ANDA)
ANDA 211045 · PURACAP LABS BLU
- 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.
