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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 202805


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NDA 202805 describes GRISEOFULVIN, ULTRAMICROSIZE, which is a drug marketed by Mountain and Sandoz and is included in two NDAs. It is available from two suppliers. Additional details are available on the GRISEOFULVIN, ULTRAMICROSIZE profile page.

The generic ingredient in GRISEOFULVIN, ULTRAMICROSIZE is griseofulvin, ultramicrosize. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.
Summary for 202805
Tradename:GRISEOFULVIN, ULTRAMICROSIZE
Applicant:Sandoz
Ingredient:griseofulvin, ultramicrosize
Patents:0
Pharmacology for NDA: 202805
Physiological EffectDecreased Mitosis
Microtubule Inhibition
Suppliers and Packaging for NDA: 202805
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRISEOFULVIN, ULTRAMICROSIZE griseofulvin, ultramicrosize TABLET;ORAL 202805 ANDA Sandoz Inc 0781-5827 0781-5827-01 100 TABLET, COATED in 1 BOTTLE (0781-5827-01)
GRISEOFULVIN, ULTRAMICROSIZE griseofulvin, ultramicrosize TABLET;ORAL 202805 ANDA Sandoz Inc 0781-5827 0781-5827-05 500 TABLET, COATED in 1 BOTTLE (0781-5827-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Dec 26, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Dec 26, 2018TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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