FDA Orange Book · active-ingredient family
Fluvoxamine maleate
Fluvoxamine maleate: 3 brands, 22 generics; first approved Dec 05, 1994; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 22 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
22
Listed patents
0
Presentations
66
Brand (NDA) products
Originator applications
- LUVOX CRRLDJAZZ PHARMSNDA 02203320082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 150MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - LUVOXRLDANI PHARMSNDA 02151920073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - LUVOXRLDSOLVAYNDA 02024319944 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued —
Generic (ANDA) products (22)
Abbreviated applications
- FLUVOXAMINE MALEATEMICRO LABSANDA 22076820262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 150MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - FLUVOXAMINE MALEATEAPPCOANDA 22032820262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 150MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - FLUVOXAMINE MALEATEANNORA PHARMAANDA 21702420252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 150MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - FLUVOXAMINE MALEATEAJANTA PHARMA LTDANDA 21905520242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 150MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - FLUVOXAMINE MALEATEBIONPHARMAANDA 21791720243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - FLUVOXAMINE MALEATEBIONPHARMAANDA 21218220202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 100MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - FLUVOXAMINE MALEATETORRENTANDA 20324020142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 150MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - FLUVOXAMINE MALEATEACTAVIS ELIZABETHANDA 09148220132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 150MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - FLUVOXAMINE MALEATEPH HEALTHANDA 09147620132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 150MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - FLUVOXAMINE MALEATECHARTWELL RXANDA 07590020063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - FLUVOXAMINE MALEATETEVAANDA 07589320023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - FLUVOXAMINE MALEATESUN PHARM INDUSTRIESANDA 07612520023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - FLUVOXAMINE MALEATEMYLANANDA 07595020012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - FLUVOXAMINE MALEATEAPOTEXANDA 07590220013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - FLUVOXAMINE MALEATEHERITAGE PHARMAANDA 07589420013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - FLUVOXAMINE MALEATEANI PHARMSANDA 07589820013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - FLUVOXAMINE MALEATEANI PHARMSANDA 07589720013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - FLUVOXAMINE MALEATESYNTHON PHARMSANDA 07589920013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - FLUVOXAMINE MALEATEUPSHER SMITH LABSANDA 07588720013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - FLUVOXAMINE MALEATEACTAVIS ELIZABETHANDA 07590120003 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - FLUVOXAMINE MALEATEAIPING PHARM INCANDA 07588820003 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - FLUVOXAMINE MALEATEQUAGENANDA 07588920003 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET 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
32 yr 2 mo ago
Most recent approval
1 mo ago
Approvals span 1994–2026 across 25 FDA applications.
Brand (NDA) 312%
Generic (ANDA) 2288%
Fluvoxamine maleate: 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.
