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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065394
Company: ACTAVIS MID ATLANTIC

Products on ANDA 065394

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065394

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/06/2007	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 065394

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

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