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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/15/2003 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-598_Vigamox.cfm |
Supplements
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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/21598s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021598Orig1s024ltr.pdf | |
05/11/2020 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021598s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021598Orig1s023ltr.pdf | |
03/14/2017 | SUPPL-22 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021598s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021598Orig1s022ltr.pdf | |
10/07/2011 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021598s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021598s017ltr.pdf | |
06/25/2004 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr008_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21598slr008ltr.pdf | |
10/03/2003 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598scp001,slr005ltr.pdf | |
04/12/2004 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr002_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21598slr002ltr.pdf | |
10/03/2003 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598scp001,slr005ltr.pdf |
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 |
VIGAMOX
SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 202525 | ADAPTIS |
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 209469 | ALEMBIC |
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 090080 | APOTEX |
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 206242 | EUGIA PHARMA |
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 208778 | GLAND PHARMA LTD |
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 202867 | LUPIN LTD |
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 206447 | MYLAN |
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 212616 | UPSHER SMITH LABS |
VIGAMOX | MOXIFLOXACIN HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT1 | 021598 | HARROW EYE |