Orange Book product · Brand (NDA)
PROPECIA
FINASTERIDE
At a glance
Dec 19, 1997
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 1997
28 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
FINASTERIDE
Strength
1MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020788
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.
- 1992PROSCARBrand (NDA)
NDA 020180 · ORGANON
- 2017FINASTERIDEGeneric (ANDA)
ANDA 207750 · ALKEM LABS LTD
- 2017FINASTERIDEGeneric (ANDA)
ANDA 204304 · ALKEM LABS LTD
- 2014FINASTERIDEGeneric (ANDA)
ANDA 077335 · CIPLA
- 2013FINASTERIDEGeneric (ANDA)
ANDA 091643 · ACCORD HLTHCARE
- 2013FINASTERIDEGeneric (ANDA)
ANDA 078371 · ACTAVIS TOTOWA
- 2013FINASTERIDEGeneric (ANDA)
ANDA 203687 · AUROBINDO PHARMA LTD
- 2013FINASTERIDEGeneric (ANDA)
ANDA 078161 · NATCO PHARMA
- 2013FINASTERIDEGeneric (ANDA)
ANDA 076905 · TEVA
- 2013FINASTERIDEGeneric (ANDA)
ANDA 090060 · HETERO LABS LTD III
- 2013FINASTERIDEGeneric (ANDA)
ANDA 090508 · SUN PHARM
- 2011FINASTERIDEGeneric (ANDA)
ANDA 090507 · SUN PHARM
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.
