Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022548
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYMAXID GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/18/2010 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022548s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022548s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022548s000_zymaxid_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022548s000_zymaxid_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/08/2016 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022548s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022548Orig1s002ltr.pdf
03/12/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/08/2016 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022548s002lbl.pdf
05/18/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022548s000lbl.pdf

ZYMAXID

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GATIFLOXACIN GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 203189 HI-TECH PHARMA CO
GATIFLOXACIN GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 202653 LUPIN LTD
GATIFLOXACIN GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 206446 MYLAN PHARMS INC
GATIFLOXACIN GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204227 SANDOZ INC
ZYMAXID GATIFLOXACIN 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 022548 ALLERGAN

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