Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022428
Company: HARROW EYE
Company: HARROW EYE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MOXEZA | MOXIFLOXACIN HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
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 |