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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217188
Company: PFIZER

Products on NDA 217188

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217188

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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/12/2025	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217188s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217188Orig1s010ltr.pdf
11/19/2024	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217188s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217188Orig1s009ltr.pdf
01/31/2025	SUPPL-8	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217188s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217188Orig1s008ltr.pdf
09/12/2024	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217188s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217188Orig1s006ltr.pdf

Labels for NDA 217188

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/12/2025	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217188s010lbl.pdf
01/31/2025	SUPPL-8	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217188s008lbl.pdf
11/19/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217188s009lbl.pdf
09/12/2024	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217188s006lbl.pdf
05/25/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217188s000lbl.pdf

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