Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 212520
Company: RVL PHARMS
Company: RVL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
UPNEEQ | OXYMETAZOLINE HYDROCHLORIDE | 0.1% | 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 |
---|---|---|---|---|---|---|---|
07/08/2020 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/0212520s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212520Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212520Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/05/2021 | SUPPL-4 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212520s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212520Orig1s004ltr.pdf | |
08/14/2020 | SUPPL-2 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212520s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212520Orig1s001s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/05/2021 | SUPPL-4 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212520s004lbl.pdf | |
08/14/2020 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212520s001s002lbl.pdf | |
07/08/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/0212520s000lbl.pdf |