Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212520
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

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