Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204251
Company: ALCON LABS INC
Company: ALCON LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SIMBRINZA | BRIMONIDINE TARTRATE; BRINZOLAMIDE | 0.2%;1% | 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 |
|---|---|---|---|---|---|---|---|
| 04/19/2013 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204251s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204251Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204251_simbrinza_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204251Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/05/2023 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204251s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204251Orig1s012ltr.pdf | |
| 06/09/2016 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/2015 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204251s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204251Orig1s006ltr.pdf | |
| 01/15/2016 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/20/2016 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/05/2023 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204251s012lbl.pdf | |
| 11/05/2015 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204251s006lbl.pdf | |
| 04/19/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204251s000lbl.pdf |