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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076538
Company: MYLAN

Products on ANDA 076538

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FEXOFENADINE HCL; PSEUDOEPHEDRINE HCL	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	60/120MG	TABLET, EXTENDED RELEASE; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076538

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2004	ORIG-1	Tentative Approval				Label is not available on this site.

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