Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076218
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LATANOPROST LATANOPROST 0.005% SOLUTION; OPHTHALMIC None (Tentative Approval) None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/09/2007 ORIG-1 Tentative Approval

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