Molindone hydrochloride
Molindone hydrochloride: 2 brands, 1 generic; first approved Mar 20, 2015; generic available.
Generic available: 1 ANDA application approved.
Brand (NDA) products
- MOBANRLDCHARTWELL RXNDA 017111—8 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — 10MG CAPSULE ORAL Discontinued — 25MG CAPSULE ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - ENDO PHARMSNDA 017938—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML CONCENTRATE ORAL Discontinued —
Generic (ANDA) products (1)
- MOLINDONE HYDROCHLORIDEEPIC PHARMA LLCANDA 09045320153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx — 10MG TABLET ORAL Rx — 25MG TABLET ORAL Rx —
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
All 3 applications were approved in 2015.
Molindone 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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