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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078559
Company: FDC LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OFLOXACIN OFLOXACIN 0.3% 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
02/25/2009 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
07/02/2020 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

03/12/2015 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

OFLOXACIN

SOLUTION/DROPS;OPHTHALMIC; 0.3%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OCUFLOX OFLOXACIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 019921 ALLERGAN
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076407 AKORN
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 202692 ALTAIRE PHARMS INC
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076513 APOTEX INC
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076622 BAUSCH AND LOMB
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078559 FDC LTD
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 215886 MANKIND PHARMA
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