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Last Updated: August 3, 2020

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GRISEOFULVIN, ULTRAMICROSIZE - Generic Drug Details

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What are the generic drug sources for griseofulvin, ultramicrosize and what is the scope of patent protection?

Griseofulvin, ultramicrosize is the generic ingredient in three branded drugs marketed by Valeant Pharms Inc, Mountain, Sandoz Inc, and Sigmapharm Labs Llc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for griseofulvin, ultramicrosize. Three suppliers are listed for this compound.

Summary for GRISEOFULVIN, ULTRAMICROSIZE
Pharmacology for GRISEOFULVIN, ULTRAMICROSIZE

US Patents and Regulatory Information for GRISEOFULVIN, ULTRAMICROSIZE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mountain GRISEOFULVIN, ULTRAMICROSIZE griseofulvin, ultramicrosize TABLET;ORAL 204371-002 Jan 9, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Valeant Pharms Inc GRIS-PEG griseofulvin, ultramicrosize TABLET;ORAL 050475-002 Approved Prior to Jan 1, 1982 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Mountain GRISEOFULVIN, ULTRAMICROSIZE griseofulvin, ultramicrosize TABLET;ORAL 204371-001 Jan 9, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Sigmapharm Labs Llc GRISEOFULVIN,ULTRAMICROSIZE griseofulvin, ultramicrosize TABLET;ORAL 202545-002 Oct 22, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc GRISEOFULVIN, ULTRAMICROSIZE griseofulvin, ultramicrosize TABLET;ORAL 202805-001 Dec 26, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc GRISEOFULVIN, ULTRAMICROSIZE griseofulvin, ultramicrosize TABLET;ORAL 202805-002 Dec 26, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Sigmapharm Labs Llc GRISEOFULVIN,ULTRAMICROSIZE griseofulvin, ultramicrosize TABLET;ORAL 202545-001 Oct 22, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Colorcon
Medtronic
Mallinckrodt
McKesson

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