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GRIS-PEG

NDA

GRISEOFULVIN, ULTRAMICROSIZE | N050475 | BAUSCH HEALTH US LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2019-P-4261 · 4 docket documents The law firm Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA designate an additional reference standard for Ultramicrocrystalline Griseofulvin Tablets, 250 mg, and amend the Orange Book to reflect ANDA 204371 held by Mountain LLC as a reference standard, because th	505(q)	2019-09-12	Granted	Hyman, Phelps & McNamara, P.C.
Emcure Pharmaceuticals USA, Inc. - Citizen Petition FDA-2008-P-0303 · 3 docket documents Emcure Pharmaceuticals USA, Inc. submitted a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to file an Abbreviated New Drug Application for griseofulvin ultramicrosize oral suspension 250 mg/5 mL, which would differ from the refere	Other	2008-05-29	Granted	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

5 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 125MG

RLDAB

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 250MG

RLDAB

0 patents0 exclusivities▾

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