FDA Orange Book · active-ingredient family
Loxapine succinate
Loxapine succinate: 1 brand, 7 generics; first approved Jun 15, 1988; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
0
Presentations
23
Brand (NDA) products
Originator applications
- LOXITANERLDTEVA BRANDED PHARMNDA 017525—7 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE CAPSULE ORAL Discontinued — EQ 10MG BASE CAPSULE ORAL Discontinued — EQ 25MG BASE CAPSULE ORAL Discontinued — EQ 50MG BASE CAPSULE ORAL Discontinued — EQ 10MG BASE **Federal Register determination that product was discontinued or withdrawn for s or e reasons** TABLET ORAL Discontinued — EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued —
Generic (ANDA) products (7)
Abbreviated applications
- LOXAPINE SUCCINATELANNETT CO INCANDA 09069520114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE CAPSULE ORAL Rx AB EQ 10MG BASE CAPSULE ORAL Rx AB EQ 25MG BASE CAPSULE ORAL Rx AB EQ 50MG BASE CAPSULE ORAL Rx AB - LOXAPINE SUCCINATEELITE LABS INCANDA 07686820054 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE CAPSULE ORAL Rx AB EQ 10MG BASE CAPSULE ORAL Rx AB EQ 25MG BASE CAPSULE ORAL Rx AB EQ 50MG BASE CAPSULE ORAL Rx AB - LOXAPINE SUCCINATERISINGANDA 07676220044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE CAPSULE ORAL Discontinued — EQ 10MG BASE CAPSULE ORAL Discontinued — EQ 25MG BASE CAPSULE ORAL Discontinued — EQ 50MG BASE CAPSULE ORAL Discontinued — - LOXAPINE SUCCINATEWATSON LABSANDA 0722041988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE CAPSULE ORAL Rx AB - LOXAPINE SUCCINATEWATSON LABSANDA 0722051988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB - LOXAPINE SUCCINATERSWATSON LABSANDA 0722061988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE CAPSULE ORAL Rx AB - LOXAPINE SUCCINATEWATSON LABSANDA 0720621988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Rx AB
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
38 yr 10 mo ago
Most recent approval
15 yr 3 mo ago
Approvals span 1988–2011 across 8 FDA applications.
Brand (NDA) 113%
Generic (ANDA) 788%
Loxapine succinate: 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.
