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FDA NDA · NDA022417

NORVIR

ritonavir

Sponsor: ABBVIE

APPLICATION
NDA022417
TYPE
NDA
ORIGINAL APPROVAL
2010-02-10
LATEST ACTION
2026-07-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NORVIR · ReferencePrescription
RITONAVIR 100MG · TABLET · ORAL

Approval history

2026-07-23Labeling · Supplement 27 · standard — Letter ↗AP
2022-12-15Labeling · Supplement 25 · standard — Letter ↗AP
2020-10-21Labeling · Supplement 24 · standard — Letter ↗AP
2019-12-19Labeling · Supplement 23 · standard — Letter ↗AP
2019-08-21Labeling · Supplement 22 · standard — Letter ↗AP
2018-11-15Labeling · Supplement 21 · standard — Label ↗AP
2017-09-29Labeling · Supplement 20 · standard — Label ↗AP
2017-06-29Labeling · Supplement 18 · standard — Label ↗AP
2017-06-07Labeling · Supplement 19 · standard — Label ↗AP
2016-12-22Labeling · Supplement 16 · standard — Label ↗AP
2016-11-22Labeling · Supplement 15 · standard — Letter ↗AP
2016-09-15Labeling · Supplement 17 · 901 required — Letter ↗AP
2015-11-10Labeling · Supplement 14 · standard — Label ↗AP
2015-03-27Labeling · Supplement 13 · 901 required — Letter ↗AP
2015-03-16Labeling · Supplement 12 · standard — Label ↗AP
2013-11-07Labeling · Supplement 10 · standard — Letter ↗AP
2012-11-20Labeling · Supplement 8 · standard — Label ↗AP
2012-02-17Labeling · Supplement 7 · 901 required — Label ↗AP
2011-12-06Labeling · Supplement 6 · standard — Letter ↗AP
2010-04-27Labeling · Supplement 1 · 901 required — Label ↗AP
2010-02-10Type 3 - New Dosage Form · Original · standard — Review ↗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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