Drugs@FDA: FDA Approved Drug Products
New Drug Application (NDA): 202872
Company: BAUSCH AND LOMB INC
Company: BAUSCH AND LOMB INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOTEMAX | LOTEPREDNOL ETABONATE | 0.5% | GEL;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 |
|---|---|---|---|---|---|---|---|
| 09/28/2012 | 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/2012/202872lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202872Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202872_lotemax_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202872Orig1s000SumR.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/28/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202872lbl.pdf |
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