Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 061996
Company: CHARTWELL RX

Products on ANDA 061996

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FULVICIN P/G	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET;ORAL	Prescription	AB	No	No
FULVICIN P/G	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET;ORAL	Prescription	AB	No	No
FULVICIN P/G 165	GRISEOFULVIN, ULTRAMICROSIZE	165MG	TABLET;ORAL	Prescription	AB	No	No
FULVICIN P/G 330	GRISEOFULVIN, ULTRAMICROSIZE	330MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 061996

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/1982	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
01/26/2001	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 061996

FULVICIN P/G

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

FULVICIN P/G 165

TABLET;ORAL; 165MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FULVICIN P/G 165	GRISEOFULVIN, ULTRAMICROSIZE	165MG	TABLET;ORAL	Prescription	No	AB	061996	CHARTWELL RX

FULVICIN P/G 330

TABLET;ORAL; 330MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FULVICIN P/G 330	GRISEOFULVIN, ULTRAMICROSIZE	330MG	TABLET;ORAL	Prescription	No	AB	061996	CHARTWELL RX