Maprotiline hydrochloride
Maprotiline hydrochloride: 1 brand, 10 generics; first approved Sep 30, 1982; generic available.
Generic available: 10 ANDA applications approved.
Brand (NDA) products
- NOVARTISNDA 017543—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued —
Generic (ANDA) products (10)
- MAPROTILINE HYDROCHLORIDERISINGANDA 07228519883 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — - MAPROTILINE HYDROCHLORIDEHERITAGE PHARMAANDA 0721621988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - MAPROTILINE HYDROCHLORIDEHERITAGE PHARMAANDA 0721631988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - MAPROTILINE HYDROCHLORIDEWATSON LABSANDA 0721641988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - MAPROTILINE HYDROCHLORIDEAM THERAPANDA 0721291988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - MAPROTILINE HYDROCHLORIDEAM THERAPANDA 0721301988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - MAPROTILINE HYDROCHLORIDEAM THERAPANDA 0721311988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - MAPROTILINE HYDROCHLORIDEWATSON LABSANDA 0719431987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - MAPROTILINE HYDROCHLORIDEWATSON LABSANDA 0719441987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - MAPROTILINE HYDROCHLORIDEWATSON LABSANDA 0719451987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued —
Listed patents
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
Approvals span 1982–1988 across 11 FDA applications.
Maprotiline 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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