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Last Updated: July 14, 2020

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Details for New Drug Application (NDA): 202482

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NDA 202482 describes GRISEOFULVIN, which is a drug marketed by Actavis Mid Atlantic, Chartwell Rx, Cipla, Cosette, Sandoz Inc, Sigmapharm Labs Llc, and Mountain, and is included in nine NDAs. It is available from five suppliers. Additional details are available on the GRISEOFULVIN profile page.

The generic ingredient in GRISEOFULVIN 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 202482
Applicant:Sigmapharm Labs Llc
Ingredient:griseofulvin, microsize
Formulation / Manufacturing:see details
Pharmacology for NDA: 202482
Suppliers and Packaging for NDA: 202482
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRISEOFULVIN griseofulvin, microsize TABLET;ORAL 202482 ANDA Sigmapharm Laboratories, LLC 42794-012 42794-012-08 30 TABLET in 1 BOTTLE (42794-012-08)
GRISEOFULVIN griseofulvin, microsize TABLET;ORAL 202482 ANDA Rising Pharmaceuticals Inc. 64980-186 64980-186-01 100 TABLET in 1 BOTTLE (64980-186-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Oct 22, 2012TE:ABRLD:No

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