Orange Book product · Brand (NDA)
JALYN
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
At a glance
Jun 14, 2010
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 14, 2010
16 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
Strength
0.5MG;0.4MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 022460
Product number
001
Marketing status
RX
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.
- 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
- 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.
