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Last Updated: September 23, 2020

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Details for New Drug Application (NDA): 204371

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NDA 204371 describes GRISEOFULVIN, ULTRAMICROSIZE, which is a drug marketed by Mountain and Sandoz Inc 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. Three suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.
Summary for 204371
Tradename:GRISEOFULVIN, ULTRAMICROSIZE
Applicant:Mountain
Ingredient:griseofulvin, ultramicrosize
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204371
Suppliers and Packaging for NDA: 204371
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRISEOFULVIN, ULTRAMICROSIZE griseofulvin, ultramicrosize TABLET;ORAL 204371 ANDA Amneal Pharmaceuticals of New York LLC 0115-1724 0115-1724-01 100 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1724-01)
GRISEOFULVIN, ULTRAMICROSIZE griseofulvin, ultramicrosize TABLET;ORAL 204371 ANDA Amneal Pharmaceuticals of New York LLC 0115-1724 0115-1724-02 500 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1724-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Jan 9, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jan 9, 2014TE:ABRLD:No

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