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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202077
Company: CARNEGIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
02/11/2013 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/11/2013 SUPPL-11

Label is not available on this site.

12/17/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LATANOPROST

SOLUTION/DROPS;OPHTHALMIC; 0.005%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 200925 AMRING PHARMS
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 201006 BAUSCH AND LOMB
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 202077 CARNEGIE
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 202442 FDC LTD
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 091449 SANDOZ
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 201786 SOMERSET
XALATAN LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 020597 UPJOHN
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