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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217188
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAXLOVID (COPACKAGED) NIRMATRELVIR; RITONAVIR 150MG;100MG TABLET;ORAL Prescription None Yes Yes
PAXLOVID (COPACKAGED) NIRMATRELVIR; RITONAVIR 300MG;100MG TABLET;ORAL 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
05/25/2023 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217188s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217188Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217188Orig1s000TOC.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/25/2023 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217188s000lbl.pdf
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