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FDA Orange Book · active-ingredient family

Perphenazine

Perphenazine: 5 brands, 15 generics; first approved Sep 10, 1987; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available — 15 ANDA applications approved.

Brands (NDA)
5
Generics (ANDA)
15
Listed patents
0
Presentations
53
Originator applications

Brand (NDA) products

NDA 0107754 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
NDA 011557
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
16MG/5MLCONCENTRATEORALDiscontinued
NDA 011213
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
5MG/MLINJECTABLEINJECTIONDiscontinued
NDA 011294
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
2MG/5MLSYRUPORALDiscontinued
NDA 011361
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
8MGTABLET, EXTENDED RELEASEORALDiscontinued
Abbreviated applications

Generic (ANDA) products (15)

ANDA 21369420254 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
2MGTABLETORALRxAB
4MGTABLETORALRxAB
8MGTABLETORALRxAB
16MGTABLETORALRxAB
ANDA 21254520244 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
2MGTABLETORALRxAB
4MGTABLETORALRxAB
8MGTABLETORALRxAB
16MGTABLETORALRxAB
ANDA 21016320224 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
2MGTABLETORALRxAB
4MGTABLETORALRxAB
8MGTABLETORALRxAB
16MGTABLETORALRxAB
ANDA 20523220204 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
2MGTABLETORALRxAB
4MGTABLETORALRxAB
8MGTABLETORALRxAB
16MGTABLETORALRxAB
ANDA 20505620194 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
2MGTABLETORALRxAB
4MGTABLETORALRxAB
8MGTABLETORALRxAB
16MGTABLETORALRxAB
ANDA 20669120174 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
2MGTABLETORALDiscontinued
4MGTABLETORALDiscontinued
8MGTABLETORALDiscontinued
16MGTABLETORALDiscontinued
ANDA 20758220164 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
2MGTABLETORALRxAB
4MGTABLETORALRxAB
8MGTABLETORALRxAB
16MGTABLETORALRxAB
ANDA 20597320154 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
2MGTABLETORALRxAB
4MGTABLETORALRxAB
8MGTABLETORALRxAB
16MGTABLETORALRxAB
ANDA 0403602001
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
16MG/5MLCONCENTRATEORALDiscontinued
ANDA 04022619984 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
2MGTABLETORALRxAB
4MGTABLETORALRxAB
8MGTABLETORALRxAB
16MGTABLETORALRxAB
ANDA 08968519884 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
8MGTABLETORALRxAB
2MGTABLETORALRxAB
4MGTABLETORALRxAB
16MGTABLETORALRxAB
ANDA 0897071987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
ANDA 0897081987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
ANDA 0894561987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
ANDA 0894571987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval
Sep 10, 1987
39 yr 5 mo ago
Most recent approval
Mar 18, 2025
1 yr 4 mo ago

Approvals span 1987–2025 across 20 FDA applications.

Brand (NDA) 525%
Generic (ANDA) 1575%

Perphenazine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

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