FDA Orange Book · active-ingredient family
Amoxapine
Amoxapine: 1 brand, 6 generics; first approved May 11, 1989; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
0
Presentations
16
Brand (NDA) products
Originator applications
- LEDERLENDA 018021—4 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 (6)
Abbreviated applications
- AMOXAPINEWATSON LABSANDA 07269119924 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - AMOXAPINECHARTWELL RXANDA 07287919914 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - AMOXAPINEWATSON PHARMS TEVAANDA 0724181989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMOXAPINEWATSON PHARMS TEVAANDA 0724191989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMOXAPINEWATSON PHARMS TEVAANDA 0724201989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMOXAPINEWATSON PHARMS TEVAANDA 0724211989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG 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
37 yr 10 mo ago
Most recent approval
34 yr 6 mo ago
Approvals span 1989–1992 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Amoxapine: 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.
