FDA Orange Book · active-ingredient family
Dutasteride; tamsulosin hydrochloride
Dutasteride; tamsulosin hydrochloride is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:JALYN · NDA 022460
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| JALYNRLD | WAYLIS THERAP | NDA 022460 | AB | Jun 14, 2010 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | AUROBINDO PHARMA | ANDA 213300 | AB | Jul 18, 2024 | |
| DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | ZYDUS PHARMS | ANDA 207769 | AB | May 24, 2018 | |
| DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | ACTAVIS LABS FL INC | ANDA 202975 | — | Nov 20, 2015 | |
| DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | PH HEALTH | ANDA 202509 | AB | Feb 26, 2014 |
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.
Dutasteride; tamsulosin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
