Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021493
Company: ALLERGAN
Company: ALLERGAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZYMAR | GATIFLOXACIN | 0.3% | 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 |
---|---|---|---|---|---|---|---|
03/28/2003 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21493_Zymar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21493ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021493_Zymar.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/21/2017 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021493s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021493Orig1s011ltr.pdf | |
05/21/2015 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021493s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021493Orig1s010ltr.pdf | |
03/21/2017 | SUPPL-9 | Efficacy-New Patient Population |
Label is not available on this site. |
||
06/20/2005 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021493s006,007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021493s006,007ltr.pdf | |
06/20/2005 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021493s006,007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021493s006,007ltr.pdf | |
07/23/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/21/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021493s011lbl.pdf | |
05/21/2015 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021493s010lbl.pdf | |
06/20/2005 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021493s006,007lbl.pdf | |
06/20/2005 | SUPPL-6 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021493s006,007lbl.pdf | |
03/28/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21493_Zymar_lbl.pdf |