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FDA NDA · NDA212887

VOCABRIA

cabotegravir sodium

Sponsor: VIIV HLTHCARE

APPLICATION
NDA212887
TYPE
NDA
ORIGINAL APPROVAL
2021-01-21
LATEST ACTION
2025-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VOCABRIA · ReferencePrescription
CABOTEGRAVIR SODIUM EQ 30MG BASE · TABLET · ORAL

Approval history

2025-04-11Labeling · Supplement 11 · standard — Letter ↗AP
2024-09-20Efficacy · Supplement 9 · priority — Letter ↗AP
2024-09-20Efficacy · Supplement 10 · standard — Letter ↗AP
2023-12-13Labeling · Supplement 8 · standard — Letter ↗AP
2023-02-27Labeling · Supplement 7 · standard — Label ↗AP
2022-03-29Efficacy · Supplement 6 · priority — Letter ↗AP
2022-03-29Efficacy · Supplement 5 · priority — Letter ↗AP
2022-03-23Efficacy · Supplement 3 · standard — Letter ↗AP
2022-02-07Efficacy · Supplement 2 · standard — Letter ↗AP
2022-01-31Efficacy · Supplement 1 · standard — Letter ↗AP
2021-12-20Efficacy · Supplement 4 · priority — Label ↗AP
2021-01-21Type 3 - New Dosage Form · Original · priority — Letter ↗AP
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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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