Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022428
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOXEZA MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT2 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
11/19/2010 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022428s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022428s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022428_moxeza_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022428Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/11/2021 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022428s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022428Orig1s010ltr.pdf
02/17/2017 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022428s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022428Orig1s009ltr.pdf
09/14/2012 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022428s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022428Orig1s002ltr.pdf
10/18/2011 SUPPL-1 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022428s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/11/2021 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022428s010lbl.pdf
02/17/2017 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022428s009lbl.pdf
02/17/2017 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022428s009lbl.pdf
09/14/2012 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022428s002lbl.pdf
11/19/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022428s000lbl.pdf

MOXEZA

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MOXEZA MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT2 022428 NOVARTIS
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT2 204079 LUPIN LTD

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