Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210821
Company: BAUSCH LOMB IRELAND
Company: BAUSCH LOMB IRELAND
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TETRACAINE HYDROCHLORIDE | TETRACAINE HYDROCHLORIDE | 0.5% | SOLUTION;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 |
---|---|---|---|---|---|---|---|
03/12/2019 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210821s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210821Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210821Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/22/2022 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210821s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210821Orig1s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/22/2022 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210821s005lbl.pdf | |
03/12/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210821s000lbl.pdf |