Orange Book product · Generic (ANDA)
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
At a glance
Feb 26, 2014
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 26, 2014
12 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
Strength
0.5MG;0.4MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 202509
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
- 2010JALYNBrand (NDA)
NDA 022460 · WAYLIS THERAP
- 2024DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 213300 · AUROBINDO PHARMA
- 2018DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 207769 · ZYDUS PHARMS
- 2015DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 202975 · ACTAVIS LABS FL INC
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.
