Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050818
Company: HARROW EYE
Company: HARROW EYE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOBRADEX ST | DEXAMETHASONE; TOBRAMYCIN | 0.05%;0.3% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
02/13/2009 | 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/2009/050818lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050818s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050818_tobradex_st_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050818s000sumr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/16/2022 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050818s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050818Orig1s007, s008, s009ltr.pdf | |
08/16/2022 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050818s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050818Orig1s007, s008, s009ltr.pdf | |
08/16/2022 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050818s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050818Orig1s007, s008, s009ltr.pdf | |
08/03/2010 | SUPPL-1 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050818s001lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/16/2022 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050818s007s008s009lbl.pdf | |
08/16/2022 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050818s007s008s009lbl.pdf | |
08/16/2022 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050818s007s008s009lbl.pdf | |
08/03/2010 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050818s001lbl.pdf | |
02/13/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050818lbl.pdf |