Orange Book product · Generic (ANDA)
FLUPHENAZINE DECANOATE
FLUPHENAZINE DECANOATE
At a glance
Nov 02, 2023
Approved
Generic (ANDA)
Application
AO
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 02, 2023
2 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUPHENAZINE DECANOATE
Strength
25MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AO
Application
ANDA 215365
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FLUPHENAZINE DECANOATE
- —PROLIXIN DECANOATEBrand (NDA)
NDA 016727 · BRISTOL MYERS SQUIBB
- 2023FLUPHENAZINE DECANOATEGeneric (ANDA)
ANDA 215509 · GLAND
- 2017FLUPHENAZINE DECANOATEGeneric (ANDA)
ANDA 207739 · EUGIA PHARMA
- 2014FLUPHENAZINE DECANOATEGeneric (ANDA)
ANDA 203732 · PH HEALTH
- 2001FLUPHENAZINE DECANOATEGeneric (ANDA)
ANDA 075918 · MYLAN LABS LTD
- 1998FLUPHENAZINE DECANOATEGeneric (ANDA)
ANDA 074966 · HOSPIRA
- 1996FLUPHENAZINE DECANOATEGeneric (ANDA)
ANDA 074795 · TEVA PARENTERAL
- 1996FLUPHENAZINE DECANOATEGeneric (ANDA)
ANDA 074531 · HIKMA
- 1987FLUPHENAZINE DECANOATEGeneric (ANDA)
ANDA 071413 · FRESENIUS KABI USA
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.
