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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202805
Company: SANDOZ

Products on ANDA 202805

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202805

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/26/2018	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 202805

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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