Treats mild-to-moderate coronavirus disease 2019 (COVID-19). NDA 217188, held by Pfizer. Nirmatrelvir; Ritonavir.
As of Nov 14, 2026, NDA 217188 (Paxlovid (Copackaged)), held by Pfizer, was first approved by FDA on May 25, 2023, with 6 approved supplements and 0 published complete response letters.
PAXLOVID is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
| Jan 31, 2025 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| May 25, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| Paxlovid (Copackaged)150MG;100MG · tablet;oral | Nirmatrelvir; Ritonavir | RxReference drug |
| Paxlovid (Copackaged)300MG;100MG · tablet;oral | Nirmatrelvir; Ritonavir | RxReference drug |
| Feb 11, 2026 | Supplement 16Labeling · Standard review | Approved | |
| Feb 11, 2026 | Supplement 17Labeling · Standard review | Approved | |
| Feb 12, 2025 | Supplement 10Labeling · Standard review | Approved | |
| Jan 31, 2025 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Nov 19, 2024 | Supplement 9Labeling · Standard review | Approved | |
| Sep 12, 2024 | Supplement 6Labeling · Standard review | Approved | |
| May 25, 2023 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
