FDA Orange Book · active-ingredient family
Fluphenazine decanoate
Fluphenazine decanoate is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PROLIXIN DECANOATE · NDA 016727
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROLIXIN DECANOATERLD | BRISTOL MYERS SQUIBB | NDA 016727 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLUPHENAZINE DECANOATE | MSN | ANDA 215365 | AO | Nov 02, 2023 | |
| FLUPHENAZINE DECANOATE | GLAND | ANDA 215509 | AO | Mar 30, 2023 | |
| FLUPHENAZINE DECANOATE | EUGIA PHARMA | ANDA 207739 | AO | Oct 17, 2017 | |
| FLUPHENAZINE DECANOATE | PH HEALTH | ANDA 203732 | AO | Jul 03, 2014 | |
| FLUPHENAZINE DECANOATE | MYLAN LABS LTD | ANDA 075918 | AO | Aug 17, 2001 | |
| FLUPHENAZINE DECANOATE | HOSPIRA | ANDA 074966 | — | Apr 16, 1998 | |
| FLUPHENAZINE DECANOATE | TEVA PARENTERAL | ANDA 074795 | — | Sep 10, 1996 | |
| FLUPHENAZINE DECANOATE | HIKMA | ANDA 074531 | AO | Aug 30, 1996 | |
| FLUPHENAZINE DECANOATE | FRESENIUS KABI USA | ANDA 071413 | AO | Jul 14, 1987 |
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.
Fluphenazine decanoate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
