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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204371
Company: MOUNTAIN

Products on ANDA 204371

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GRISEOFULVIN, ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET;ORAL	Prescription	AB	No	No
GRISEOFULVIN, ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204371

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/09/2014	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/20/2025	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204371

GRISEOFULVIN, ULTRAMICROSIZE

TABLET;ORAL; 125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FULVICIN P/G	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET;ORAL	Prescription	No	AB	061996	CHARTWELL RX
GRIS-PEG	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET;ORAL	Prescription	Yes	AB	050475	BAUSCH
GRISEOFULVIN, ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET;ORAL	Prescription	No	AB	204371	MOUNTAIN
GRISEOFULVIN, ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET;ORAL	Prescription	No	AB	202805	SANDOZ
GRISEOFULVIN,ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET;ORAL	Prescription	No	AB	202545	SIGMAPHARM LABS LLC

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FULVICIN P/G	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET;ORAL	Prescription	No	AB	061996	CHARTWELL RX
GRIS-PEG	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET;ORAL	Prescription	Yes	AB	050475	BAUSCH
GRISEOFULVIN, ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET;ORAL	Prescription	No	AB	204371	MOUNTAIN
GRISEOFULVIN, ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET;ORAL	Prescription	No	AB	202805	SANDOZ
GRISEOFULVIN,ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET;ORAL	Prescription	No	AB	202545	SIGMAPHARM LABS LLC

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