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FDA NDA · NDA217188

PAXLOVID

nirmatrelvir and ritonavir

Sponsor: PFIZER

APPLICATION
NDA217188
TYPE
NDA
ORIGINAL APPROVAL
2023-05-25
LATEST ACTION
2026-02-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PAXLOVID (COPACKAGED) · ReferencePrescription
NIRMATRELVIR 300MG, RITONAVIR 100MG · TABLET · ORAL
PAXLOVID (COPACKAGED) · ReferencePrescription
NIRMATRELVIR 150MG, RITONAVIR 100MG · TABLET · ORAL

Approval history

2026-02-11Labeling · Supplement 16 · standard — Letter ↗AP
2026-02-11Labeling · Supplement 17 · standard — Letter ↗AP
2025-02-12Labeling · Supplement 10 · standard — Letter ↗AP
2025-01-31Efficacy · Supplement 8 · priority — Label ↗AP
2024-11-19Labeling · Supplement 9 · standard — Label ↗AP
2024-09-12Labeling · Supplement 6 · standard — Label ↗AP
2023-05-25Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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