Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208219
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 SM | LOTEPREDNOL ETABONATE | 0.38% | 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 |
---|---|---|---|---|---|---|---|
02/22/2019 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208219s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208219Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/208219Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/22/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208219s000lbl.pdf |