FDA Orange Book · active-ingredient family
Fluphenazine hydrochloride
Fluphenazine hydrochloride: 5 brands, 31 generics; first approved Nov 07, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 31 ANDA applications approved.
Brands (NDA)
5
Generics (ANDA)
31
Listed patents
0
Presentations
106
Brand (NDA) products
Originator applications
- PROLIXINRLDAPOTHECONNDA 012145—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/5ML ELIXIR ORAL Discontinued — - PROLIXINRLDAPOTHECONNDA 011751—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2.5MG/ML INJECTABLE INJECTION Discontinued — - SCHERINGNDA 016008—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML CONCENTRATE ORAL Discontinued — - SCHERINGNDA 012419—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET, EXTENDED RELEASE ORAL Discontinued — - SCHERINGNDA 012034—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued —
Generic (ANDA) products (31)
Abbreviated applications
- FLUPHENAZINE HYDROCHLORIDEHETERO LABS LTD IIIANDA 21876920254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDEALEMBICANDA 21817320244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDERISINGANDA 21828320244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDETORRENTANDA 21709420244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - FLUPHENAZINE HYDROCHLORIDEGLENMARK PHARMS LTDANDA 21635020234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDEMSNANDA 21718920234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 21805520234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDEAJANTA PHARMA LTDANDA 21741020234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDETWI PHARMSANDA 21584820224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — - FLUPHENAZINE HYDROCHLORIDEBRECKENRIDGEANDA 21689120224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - FLUPHENAZINE HYDROCHLORIDEUPSHER SMITH LABSANDA 21378420224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDEAPOTEXANDA 21664920224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - FLUPHENAZINE HYDROCHLORIDETAROANDA 21567420224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDEZAMEER PHARMSANDA 21514120214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDEZYDUS LIFESCIENCESANDA 21455220214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDENOVITIUM PHARMAANDA 21467420214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDEDR REDDYSANDA 21453420214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDEAMNEALANDA 21364720204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDERSPHARM ASSOCANDA 0747251996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML CONCENTRATE ORAL Rx — - FLUPHENAZINE HYDROCHLORIDERSPHARM ASSOCANDA 0401461996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/5ML ELIXIR ORAL Rx — - FLUPHENAZINE HYDROCHLORIDEANI PHARMSANDA 0813101993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/5ML ELIXIR ORAL Discontinued — - FLUPHENAZINE HYDROCHLORIDEANI PHARMSANDA 0730581991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML CONCENTRATE ORAL Discontinued — - FLUPHENAZINE HYDROCHLORIDELANNETT CO INCANDA 08974319884 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB - FLUPHENAZINE HYDROCHLORIDEPRASCOANDA 08980419884 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — - FLUPHENAZINE HYDROCHLORIDEWATSON LABSANDA 0885551987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FLUPHENAZINE HYDROCHLORIDEWATSON LABSANDA 0885441987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - FLUPHENAZINE HYDROCHLORIDEWATSON LABSANDA 0885271987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - FLUPHENAZINE HYDROCHLORIDEWATSON LABSANDA 0885501987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - FLUPHENAZINE HYDROCHLORIDESANDOZANDA 08958619874 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — - FLUPHENAZINE HYDROCHLORIDERSFRESENIUS KABI USAANDA 0895561987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/ML INJECTABLE INJECTION Rx — - APOTHECONANDA 0705331985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML CONCENTRATE ORAL Discontinued —
Listed patents
Orange Book patent file
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
FDA approval span
First approval
41 yr 6 mo ago
Most recent approval
11 mo ago
Approvals span 1985–2025 across 36 FDA applications.
Brand (NDA) 514%
Generic (ANDA) 3186%
Fluphenazine hydrochloride: 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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