Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208254
Company: AERIE PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RHOPRESSA NETARSUDIL DIMESYLATE 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
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
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

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