Orange Book product · Brand (NDA)
PROLIXIN DECANOATE
FLUPHENAZINE DECANOATE
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 DECANOATE
Strength
25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 016727
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.
- 2023FLUPHENAZINE DECANOATEGeneric (ANDA)
ANDA 215365 · MSN
- 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.
