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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076935
Company: SANDOZ

Products on ANDA 076935

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MODAFINIL	MODAFINIL	100MG	TABLET; ORAL	None (Tentative Approval)	None	No	No
MODAFINIL	MODAFINIL	200MG	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076935

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2006	ORIG-1	Tentative Approval				Label is not available on this site.

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