Orange Book product · Brand (NDA)
PERMITIL
FLUPHENAZINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
FLUPHENAZINE HYDROCHLORIDE
Strength
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CONCENTRATE
Route
ORAL
TE code
Not listed
Application
NDA 016008
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- —PROLIXINBrand (NDA)
NDA 012145 · APOTHECON
- —PROLIXINBrand (NDA)
NDA 011751 · APOTHECON
- —PERMITILBrand (NDA)
NDA 012419 · SCHERING
- —PERMITILBrand (NDA)
NDA 012034 · SCHERING
- 2025FLUPHENAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218769 · HETERO LABS LTD III
- 2024FLUPHENAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218173 · ALEMBIC
- 2024FLUPHENAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218283 · RISING
- 2024FLUPHENAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217094 · TORRENT
- 2023FLUPHENAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216350 · GLENMARK PHARMS LTD
- 2023FLUPHENAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217189 · MSN
- 2023FLUPHENAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218055 · AUROBINDO PHARMA LTD
- 2023FLUPHENAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217410 · AJANTA PHARMA LTD
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.
