Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091592
Company: SANDOZ

Products on ANDA 091592

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GRISEOFULVIN	GRISEOFULVIN, MICROSIZE	250MG	TABLET;ORAL	Prescription	AB	No	No
GRISEOFULVIN	GRISEOFULVIN, MICROSIZE	500MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091592

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/2013	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Therapeutic Equivalents for ANDA 091592

GRISEOFULVIN

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FULVICIN-U/F	GRISEOFULVIN, MICROSIZE	250MG	TABLET;ORAL	Prescription	No	AB	060569	CHARTWELL RX
GRISEOFULVIN	GRISEOFULVIN, MICROSIZE	250MG	TABLET;ORAL	Prescription	No	AB	091592	SANDOZ

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FULVICIN-U/F	GRISEOFULVIN, MICROSIZE	500MG	TABLET;ORAL	Prescription	No	AB	060569	CHARTWELL RX
GRISEOFULVIN	GRISEOFULVIN, MICROSIZE	500MG	TABLET;ORAL	Prescription	No	AB	091592	SANDOZ
GRISEOFULVIN	GRISEOFULVIN, MICROSIZE	500MG	TABLET;ORAL	Prescription	No	AB	202482	SIGMAPHARM LABS LLC