FDA Orange Book · active-ingredient family
Perphenazine
Perphenazine is approved as 5 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TRILAFON · NDA 010775
5
Brand (NDA)
15
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · concentrate, injectable, syrup, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRILAFONRLD×4 | SCHERING | NDA 010775 | — | Approved Prior to Jan 1, 1982 | |
| TRILAFON | SCHERING | NDA 011557 | — | Approved Prior to Jan 1, 1982 | |
| TRILAFON | SCHERING | NDA 011213 | — | Approved Prior to Jan 1, 1982 | |
| TRILAFON | SCHERING | NDA 011294 | — | Approved Prior to Jan 1, 1982 | |
| TRILAFON | SCHERING | NDA 011361 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PERPHENAZINE×4 | JUBILANT GENERICS | ANDA 213694 | AB | Mar 18, 2025 | |
| PERPHENAZINE×4 | MACLEODS PHARMS LTD | ANDA 212545 | AB | May 06, 2024 | |
| PERPHENAZINE×4 | APPCO | ANDA 210163 | AB | May 18, 2022 | |
| PERPHENAZINE×4 | ZYDUS PHARMS | ANDA 205232 | AB | Apr 06, 2020 | |
| PERPHENAZINE×4 | RISING | ANDA 205056 | AB | Mar 01, 2019 | |
| PERPHENAZINE×4 | MYLAN | ANDA 206691 | — | Apr 14, 2017 | |
| PERPHENAZINE×4 | WATSON LABS INC | ANDA 207582 | AB | Oct 17, 2016 | |
| PERPHENAZINE×4 | WILSHIRE PHARMS INC | ANDA 205973 | AB | Dec 17, 2015 | |
| PERPHENAZINE | PHARM ASSOC | ANDA 040360 | — | May 25, 2001 | |
| PERPHENAZINE×4 | PH HEALTH | ANDA 040226 | AB | Dec 31, 1998 | |
| PERPHENAZINE×4 | SANDOZ | ANDA 089685 | AB | Dec 08, 1988 | |
| PERPHENAZINE | ANI PHARMS | ANDA 089707 | — | Sep 10, 1987 | |
| PERPHENAZINE | ANI PHARMS | ANDA 089708 | — | Sep 10, 1987 | |
| PERPHENAZINE | ANI PHARMS | ANDA 089456 | — | Sep 10, 1987 | |
| PERPHENAZINE | ANI PHARMS | ANDA 089457 | — | Sep 10, 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.
Perphenazine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
