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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076513
Company: APOTEX INC
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
05/14/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76513ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/13/2019 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

07/20/2020 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

08/06/2008 SUPPL-15 Labeling

Label is not available on this site.

02/26/2014 SUPPL-10 Labeling

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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