Orange Book product · Generic (ANDA)
NAFTIFINE HYDROCHLORIDE
NAFTIFINE HYDROCHLORIDE
At a glance
Apr 10, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 10, 2019
7 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
NAFTIFINE HYDROCHLORIDE
Strength
2%
Dosage form
GEL
Route
TOPICAL
TE code
AB
Application
ANDA 208201
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NAFTIFINE HYDROCHLORIDE
- 2013NAFTINBrand (NDA)
NDA 204286 · LEGACY PHARMA
- 1990NAFTINBrand (NDA)
NDA 019356 · LEGACY PHARMA
- 1988NAFTINBrand (NDA)
NDA 019599 · LEGACY PHARMA
- 2020NAFTIFINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210038 · XIROMED
- 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.
