Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208254
Company: ALCON LABS INC
Company: ALCON LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RHOPRESSA | NETARSUDIL MESYLATE | EQ 0.02% BASE | SOLUTION/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 |
---|---|---|---|---|---|---|---|
12/18/2017 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
httpS://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208254lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208254Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208254Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/18/2024 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208254s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208254Orig1s014ltr.pdf | |
03/22/2019 | SUPPL-3 | Labeling-Patient Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208254s003lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/18/2024 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208254s014lbl.pdf | |
03/22/2019 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208254s003lbl.pdf | |
12/18/2017 | ORIG-1 | Approval | Label (PDF) | httpS://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208254lbl.pdf |