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
TRILAFONRLDSCHERINGNDA 010775—4 strengths
TRILAFONRLD
SCHERINGNDA 010775—4 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
| 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
| 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
| 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
SCHERINGNDA 011557—
SCHERINGNDA 011557—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 16MG/5ML | CONCENTRATE | ORAL | Discontinued | — |
SCHERINGNDA 011213—
SCHERINGNDA 011213—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
SCHERINGNDA 011294—
SCHERINGNDA 011294—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG/5ML | SYRUP | ORAL | Discontinued | — |
SCHERINGNDA 011361—
SCHERINGNDA 011361—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 8MG | TABLET, EXTENDED RELEASE | ORAL | Discontinued | — |
Abbreviated applications
Generic (ANDA) products (15)
JUBILANT GENERICSANDA 21369420254 strengths
JUBILANT GENERICSANDA 21369420254 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Rx | AB |
| 4MG | TABLET | ORAL | Rx | AB |
| 8MG | TABLET | ORAL | Rx | AB |
| 16MG | TABLET | ORAL | Rx | AB |
MACLEODS PHARMS LTDANDA 21254520244 strengths
MACLEODS PHARMS LTDANDA 21254520244 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Rx | AB |
| 4MG | TABLET | ORAL | Rx | AB |
| 8MG | TABLET | ORAL | Rx | AB |
| 16MG | TABLET | ORAL | Rx | AB |
APPCOANDA 21016320224 strengths
APPCOANDA 21016320224 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Rx | AB |
| 4MG | TABLET | ORAL | Rx | AB |
| 8MG | TABLET | ORAL | Rx | AB |
| 16MG | TABLET | ORAL | Rx | AB |
ZYDUS PHARMSANDA 20523220204 strengths
ZYDUS PHARMSANDA 20523220204 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Rx | AB |
| 4MG | TABLET | ORAL | Rx | AB |
| 8MG | TABLET | ORAL | Rx | AB |
| 16MG | TABLET | ORAL | Rx | AB |
RISINGANDA 20505620194 strengths
RISINGANDA 20505620194 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Rx | AB |
| 4MG | TABLET | ORAL | Rx | AB |
| 8MG | TABLET | ORAL | Rx | AB |
| 16MG | TABLET | ORAL | Rx | AB |
MYLANANDA 20669120174 strengths
MYLANANDA 20669120174 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
| 4MG | TABLET | ORAL | Discontinued | — |
| 8MG | TABLET | ORAL | Discontinued | — |
| 16MG | TABLET | ORAL | Discontinued | — |
WATSON LABS INCANDA 20758220164 strengths
WATSON LABS INCANDA 20758220164 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Rx | AB |
| 4MG | TABLET | ORAL | Rx | AB |
| 8MG | TABLET | ORAL | Rx | AB |
| 16MG | TABLET | ORAL | Rx | AB |
WILSHIRE PHARMS INCANDA 20597320154 strengths
WILSHIRE PHARMS INCANDA 20597320154 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Rx | AB |
| 4MG | TABLET | ORAL | Rx | AB |
| 8MG | TABLET | ORAL | Rx | AB |
| 16MG | TABLET | ORAL | Rx | AB |
PHARM ASSOCANDA 0403602001
PHARM ASSOCANDA 0403602001
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 16MG/5ML | CONCENTRATE | ORAL | Discontinued | — |
PH HEALTHANDA 04022619984 strengths
PH HEALTHANDA 04022619984 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Rx | AB |
| 4MG | TABLET | ORAL | Rx | AB |
| 8MG | TABLET | ORAL | Rx | AB |
| 16MG | TABLET | ORAL | Rx | AB |
SANDOZANDA 08968519884 strengths
SANDOZANDA 08968519884 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 8MG | TABLET | ORAL | Rx | AB |
| 2MG | TABLET | ORAL | Rx | AB |
| 4MG | TABLET | ORAL | Rx | AB |
| 16MG | TABLET | ORAL | Rx | AB |
ANI PHARMSANDA 0897071987
ANI PHARMSANDA 0897071987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
ANI PHARMSANDA 0897081987
ANI PHARMSANDA 0897081987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
ANI PHARMSANDA 0894561987
ANI PHARMSANDA 0894561987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
ANI PHARMSANDA 0894571987
ANI PHARMSANDA 0894571987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

