Fluphenazine decanoate
Fluphenazine decanoate: 1 brand, 9 generics; first approved Jul 14, 1987; generic available.
Generic available: 9 ANDA applications approved.
Brand (NDA) products
- BRISTOL MYERS SQUIBBNDA 016727—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (9)
- FLUPHENAZINE DECANOATEMSNANDA 2153652023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AO - FLUPHENAZINE DECANOATEGLANDANDA 2155092023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AO - FLUPHENAZINE DECANOATEEUGIA PHARMAANDA 2077392017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AO - FLUPHENAZINE DECANOATEPH HEALTHANDA 2037322014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AO - FLUPHENAZINE DECANOATEMYLAN LABS LTDANDA 0759182001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AO - FLUPHENAZINE DECANOATEHOSPIRAANDA 0749661998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - FLUPHENAZINE DECANOATETEVA PARENTERALANDA 0747951996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - FLUPHENAZINE DECANOATEHIKMAANDA 0745311996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AO - FLUPHENAZINE DECANOATERSFRESENIUS KABI USAANDA 0714131987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Rx AO
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.
Approval history
Approvals span 1987–2023 across 10 FDA applications.
Fluphenazine decanoate: 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 BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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