Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076826
Company: WATSON LABS TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOFLOXACIN LEVOFLOXACIN 0.5% 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
02/10/2011 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
07/13/2017 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LEVOFLOXACIN

SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOFLOXACIN LEVOFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090268 AKORN
LEVOFLOXACIN LEVOFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204899 MYLAN LABS LTD
LEVOFLOXACIN LEVOFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077700 RISING PHARMS
LEVOFLOXACIN LEVOFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076826 WATSON LABS TEVA

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