Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091449
Company: SANDOZ INC

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
03/22/2011 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/19/2020 SUPPL-6 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 090887 AKORN
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 DR REDDYS LABS LTD
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 INC
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 201786 SOMERSET
XALATAN LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 020597 PHARMACIA AND UPJOHN

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