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GRIFULVIN V

ANDA

GRISEOFULVIN, MICROCRYSTALLINE | A062279 | VALEANT PHARMACEUTICALS LUXEMBOURG SARL

3 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Olsson Frank Weeda Terman Bode Matz PC - Citizen Petition FDA-2011-P-0025 · 5 docket documents The law firm Olsson Frank Weeda Terman Bode Matz PC filed this citizen petition on behalf of a client requesting that the FDA determine that Grifulvin V (griseofulvin microcrystalline) Tablets, 250 mg, approved under ANDA 062279 and sponsored by OrthoNeutrogena, was not voluntarily withdrawn from th	505(q)	2011-01-14	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Products (3)

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#001 — 125MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 500MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982