Griseofulvin, ultramicrosize
Griseofulvin, ultramicrosize: 1 brand, 4 generics; first approved Apr 06, 1982; generic available.
Generic available: 4 ANDA applications approved.
Brand (NDA) products
- GRIS-PEGRLDBAUSCHNDA 050475—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB
Generic (ANDA) products (4)
- GRISEOFULVIN, ULTRAMICROSIZESANDOZANDA 20280520182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - GRISEOFULVIN, ULTRAMICROSIZEMOUNTAINANDA 20437120142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - GRISEOFULVIN,ULTRAMICROSIZESIGMAPHARM LABS LLCANDA 20254520122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - CHARTWELL RXANDA 061996—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB 165MG TABLET ORAL Rx — 330MG 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
Approvals span 1982–2018 across 5 FDA applications.
Griseofulvin, ultramicrosize: 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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