Orange Book product · Brand (NDA)
NAFTIN
NAFTIFINE HYDROCHLORIDE
At a glance
Jan 13, 2012
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 13, 2012
14 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
NAFTIFINE HYDROCHLORIDE
Strength
2%
Dosage form
CREAM
Route
TOPICAL
TE code
AB
Application
NDA 019599
Product number
002
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.
- 2013NAFTINBrand (NDA)
NDA 204286 · LEGACY PHARMA
- 1990NAFTINBrand (NDA)
NDA 019356 · LEGACY PHARMA
- 2020NAFTIFINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210038 · XIROMED
- 2019NAFTIFINE HYDROCHLORIDEGeneric (ANDA)
ANDA 208201 · SUN PHARMA CANADA
- 2019NAFTIFINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206165 · AMNEAL
- 2017NAFTIFINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206960 · AMNEAL
- 2016NAFTIFINE HYDROCHLORIDEGeneric (ANDA)
ANDA 205975 · SUN PHARMA CANADA
- 2016NAFTIFINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206901 · SUN PHARMA CANADA
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.
