FDA Orange Book · active-ingredient family
Mirtazapine
Mirtazapine: 2 brands, 24 generics; first approved Jun 14, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 24 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
24
Listed patents
0
Presentations
84
Brand (NDA) products
Originator applications
- ORGANON USA ORGANONNDA 02120820013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 30MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 45MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - ORGANONNDA 02041519963 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 45MG TABLET ORAL Discontinued —
Generic (ANDA) products (24)
Abbreviated applications
- MIRTAZAPINEMICRO LABSANDA 22010420264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 45MG TABLET ORAL Rx AB - MIRTAZAPINENOVITIUM PHARMAANDA 21991920264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 45MG TABLET ORAL Rx AB - MIRTAZAPINEANNORA PHARMAANDA 21972120254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 45MG TABLET ORAL Rx AB - MIRTAZAPINEPRASCOANDA 21675120234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 45MG TABLET ORAL Rx AB - MIRTAZAPINESQUARE PHARMS PLCANDA 20579820173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 30MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 45MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - MIRTAZAPINEACTAVIS ELIZABETHANDA 07795920113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 30MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 45MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - MIRTAZAPINEAPOTEXANDA 07766620073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 45MG TABLET ORAL Rx AB - MIRTAZAPINEAUROBINDO PHARMAANDA 07737620053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 30MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 45MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - MIRTAZAPINEACTAVIS ELIZABETHANDA 07668920053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 30MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 45MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - MIRTAZAPINEIMPAX LABS INCANDA 07690120053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 30MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 45MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - MIRTAZAPINEAUROBINDOANDA 07692120044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 45MG TABLET ORAL Rx AB - MIRTAZAPINESUN PHARM INDS INCANDA 07654120044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 45MG TABLET ORAL Rx AB 7.5MG TABLET ORAL Rx AB - MIRTAZAPINEIVAX SUB TEVA PHARMSANDA 07624420033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 45MG TABLET ORAL Discontinued — - MIRTAZAPINEACTAVIS LABS FL INCANDA 07630720033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 30MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 45MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - MIRTAZAPINEACTAVIS ELIZABETHANDA 07624120033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 45MG TABLET ORAL Discontinued — - MIRTAZAPINEACTAVIS ELIZABETHANDA 07630820033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 45MG TABLET ORAL Discontinued — - MIRTAZAPINEACTAVIS LABS FL INCANDA 07633620033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 45MG TABLET ORAL Discontinued — - MIRTAZAPINECHARTWELL RXANDA 07621920033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 45MG TABLET ORAL Rx AB - MIRTAZAPINEMYLANANDA 07612220033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 45MG TABLET ORAL Rx AB - MIRTAZAPINEROXANEANDA 07627020033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 45MG TABLET ORAL Discontinued — - MIRTAZAPINESENORES PHARMSANDA 07617620033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 45MG TABLET ORAL Discontinued — - MIRTAZAPINEUPSHER SMITH LABSANDA 07618920033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 45MG TABLET ORAL Discontinued — - MIRTAZAPINEWATSON LABSANDA 07631220033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 45MG TABLET ORAL Discontinued — - MIRTAZAPINETEVAANDA 07611920033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 45MG TABLET 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
30 yr 9 mo ago
Most recent approval
5 mo ago
Approvals span 1996–2026 across 26 FDA applications.
Brand (NDA) 28%
Generic (ANDA) 2492%
Mirtazapine: 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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