Orange Book product · Brand (NDA)
AVODART
DUTASTERIDE
At a glance
Nov 20, 2001
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 20, 2001
24 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
DUTASTERIDE
Strength
0.5MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 021319
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2018DUTASTERIDEGeneric (ANDA)
ANDA 208227 · STRIDES PHARMA
- 2017DUTASTERIDEGeneric (ANDA)
ANDA 209909 · HUMANWELL PURACAP
- 2017DUTASTERIDEGeneric (ANDA)
ANDA 207935 · HERITAGE PHARMS INC
- 2017DUTASTERIDEGeneric (ANDA)
ANDA 204373 · ZYDUS LIFESCIENCES
- 2017DUTASTERIDEGeneric (ANDA)
ANDA 204376 · ADAPTIS
- 2016DUTASTERIDEGeneric (ANDA)
ANDA 206574 · ASCENT PHARMS INC
- 2016DUTASTERIDEGeneric (ANDA)
ANDA 203241 · PHARMOBEDIENT
- 2016DUTASTERIDEGeneric (ANDA)
ANDA 206373 · ACELLA
- 2015DUTASTERIDEGeneric (ANDA)
ANDA 204292 · APOTEX
- 2015DUTASTERIDEGeneric (ANDA)
ANDA 202204 · HIKMA
- 2015DUTASTERIDEGeneric (ANDA)
ANDA 202808 · ACTAVIS LABS FL INC
- 2015DUTASTERIDEGeneric (ANDA)
ANDA 203118 · AMNEAL PHARMS
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.
