Orange Book product · Brand (NDA)
NAFTIN
NAFTIFINE HYDROCHLORIDE
At a glance
Feb 29, 1988
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 29, 1988
38 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
NAFTIFINE HYDROCHLORIDE
Strength
1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 019599
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
