Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050804
Company: BAUSCH AND LOMB
Company: BAUSCH AND LOMB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZYLET | LOTEPREDNOL ETABONATE; TOBRAMYCIN | 0.5%;0.3% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/25/2021 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050804s026lbl.pdf | |
| 02/06/2013 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050804s018lbl.pdf | |
| 10/02/2012 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050804s017lbl.pdf | |
| 06/03/2010 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050804s015lbl.pdf | |
| 12/14/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050804lbl.pdf |