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FDA NDA · NDA209512

NORVIR

ritonavir

Sponsor: ABBVIE

APPLICATION
NDA209512
TYPE
NDA
ORIGINAL APPROVAL
2017-06-07
LATEST ACTION
2026-07-23
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

NORVIR · ReferencePrescription
RITONAVIR 100MG/PACKET · POWDER · ORAL

Approval history

2026-07-23Labeling · Supplement 10 · standard — Letter ↗AP
2022-12-15Labeling · Supplement 8 · standard — Letter ↗AP
2020-10-21Labeling · Supplement 7 · standard — Letter ↗AP
2019-12-19Labeling · Supplement 6 · standard — Letter ↗AP
2019-08-21Labeling · Supplement 5 · standard — Letter ↗AP
2018-11-15Labeling · Supplement 4 · standard — Label ↗AP
2017-09-29Labeling · Supplement 2 · standard — Label ↗AP
2017-06-29Labeling · Supplement 1 · standard — Label ↗AP
2017-06-07Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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