Orange Book product · Generic (ANDA)
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
At a glance
May 24, 2018
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 24, 2018
8 yr 2 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 207769
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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
- 2015DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 202975 · ACTAVIS LABS FL INC
- 2014DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 202509 · 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.
