Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021598
Company: HARROW EYE
Company: HARROW EYE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIGAMOX | MOXIFLOXACIN HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT1 | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/02/2020 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/21598s024lbl.pdf | |
| 05/11/2020 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021598s023lbl.pdf | |
| 03/14/2017 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021598s022lbl.pdf | |
| 03/14/2017 | SUPPL-22 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021598s022lbl.pdf | |
| 10/07/2011 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021598s017lbl.pdf | |
| 06/25/2004 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr008_vigamox_lbl.pdf | |
| 04/12/2004 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr002_vigamox_lbl.pdf | |
| 10/03/2003 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf | |
| 10/03/2003 | SUPPL-1 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf | |
| 04/15/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598_vigamox_lbl.pdf |