Orange Book product · Generic (ANDA)
FESOTERODINE FUMARATE
FESOTERODINE FUMARATE
At a glance
Jan 05, 2023
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 05, 2023
3 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
FESOTERODINE FUMARATE
Strength
4MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 204983
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FESOTERODINE FUMARATE
- 2008TOVIAZBrand (NDA)
NDA 022030 · PFIZER
- 2024FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204792 · HETERO LABS LTD V
- 2023FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 205012 · ACCORD HLTHCARE
- 2023FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204868 · ACTAVIS LABS FL INC
- 2023FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204973 · ALEMBIC
- 2023FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 205002 · AMNEAL PHARMS NY
- 2023FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204504 · ANI PHARMS
- 2019FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204975 · DR REDDYS
- 2017FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204946 · ZYDUS PHARMS
- 2017FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 205007 · AUROBINDO PHARMA
- 2015FESOTERODINE FUMARATEGeneric (ANDA)
ANDA 204827 · ALKEM LABS LTD
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.
