FDA Orange Book · active-ingredient family
Fluphenazine hydrochloride
Fluphenazine hydrochloride is approved as 5 brand and 31 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PROLIXIN · NDA 012145
5
Brand (NDA)
31
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · concentrate, elixir, injectable, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROLIXINRLD | APOTHECON | NDA 012145 | — | Approved Prior to Jan 1, 1982 | |
| PROLIXINRLD×5 | APOTHECON | NDA 011751 | — | Approved Prior to Jan 1, 1982 | |
| PERMITIL | SCHERING | NDA 016008 | — | Approved Prior to Jan 1, 1982 | |
| PERMITIL | SCHERING | NDA 012419 | — | Approved Prior to Jan 1, 1982 | |
| PERMITIL×4 | SCHERING | NDA 012034 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (31)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLUPHENAZINE HYDROCHLORIDE×4 | HETERO LABS LTD III | ANDA 218769 | AB | Nov 18, 2025 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | ALEMBIC | ANDA 218173 | AB | Jul 23, 2024 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | RISING | ANDA 218283 | AB | Jun 07, 2024 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | TORRENT | ANDA 217094 | — | Jan 22, 2024 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | GLENMARK PHARMS LTD | ANDA 216350 | AB | Nov 06, 2023 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | MSN | ANDA 217189 | AB | Sep 11, 2023 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | AUROBINDO PHARMA LTD | ANDA 218055 | AB | Aug 18, 2023 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | AJANTA PHARMA LTD | ANDA 217410 | AB | Jan 05, 2023 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | TWI PHARMS | ANDA 215848 | — | Dec 14, 2022 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | BRECKENRIDGE | ANDA 216891 | — | Nov 15, 2022 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | UPSHER SMITH LABS | ANDA 213784 | AB | Oct 24, 2022 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | APOTEX | ANDA 216649 | — | Jul 15, 2022 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | TARO | ANDA 215674 | AB | Apr 14, 2022 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | ZAMEER PHARMS | ANDA 215141 | AB | Oct 20, 2021 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | ZYDUS LIFESCIENCES | ANDA 214552 | AB | May 27, 2021 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | NOVITIUM PHARMA | ANDA 214674 | AB | Mar 01, 2021 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | DR REDDYS | ANDA 214534 | AB | Jan 07, 2021 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | AMNEAL | ANDA 213647 | AB | Jul 09, 2020 | |
| FLUPHENAZINE HYDROCHLORIDE | PHARM ASSOC | ANDA 074725 | — | Sep 16, 1996 | |
| FLUPHENAZINE HYDROCHLORIDE | PHARM ASSOC | ANDA 040146 | — | Aug 21, 1996 | |
| FLUPHENAZINE HYDROCHLORIDE | ANI PHARMS | ANDA 081310 | — | Apr 29, 1993 | |
| FLUPHENAZINE HYDROCHLORIDE | ANI PHARMS | ANDA 073058 | — | Aug 30, 1991 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | LANNETT CO INC | ANDA 089743 | AB | Aug 25, 1988 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | PRASCO | ANDA 089804 | — | Aug 12, 1988 | |
| FLUPHENAZINE HYDROCHLORIDE | WATSON LABS | ANDA 088555 | — | Dec 18, 1987 | |
| FLUPHENAZINE HYDROCHLORIDE | WATSON LABS | ANDA 088544 | — | Dec 18, 1987 | |
| FLUPHENAZINE HYDROCHLORIDE | WATSON LABS | ANDA 088527 | — | Dec 18, 1987 | |
| FLUPHENAZINE HYDROCHLORIDE | WATSON LABS | ANDA 088550 | — | Dec 18, 1987 | |
| FLUPHENAZINE HYDROCHLORIDE×4 | SANDOZ | ANDA 089586 | — | Oct 16, 1987 | |
| FLUPHENAZINE HYDROCHLORIDE | FRESENIUS KABI USA | ANDA 089556 | — | Apr 16, 1987 | |
| PROLIXIN | APOTHECON | ANDA 070533 | — | Nov 07, 1985 |
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 hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
