Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065200
Company: CHARTWELL RX

Products on ANDA 065200

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GRISEOFULVIN	GRISEOFULVIN, MICROSIZE	125MG/5ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065200

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/02/2005	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/065200_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/31/2007	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065200

GRISEOFULVIN

SUSPENSION;ORAL; 125MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GRISEOFULVIN	GRISEOFULVIN, MICROSIZE	125MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	065394	ACTAVIS MID ATLANTIC
GRISEOFULVIN	GRISEOFULVIN, MICROSIZE	125MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	065200	CHARTWELL RX
GRISEOFULVIN	GRISEOFULVIN, MICROSIZE	125MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	065354	CIPLA
GRISEOFULVIN	GRISEOFULVIN, MICROSIZE	125MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	065438	COSETTE