← FDA DRUG APPROVALS

FDA NDA · NDA208573

VENCLEXTA

venetoclax

Sponsor: ABBVIE

APPLICATION
NDA208573
TYPE
NDA
ORIGINAL APPROVAL
2016-04-11
LATEST ACTION
2026-05-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VENCLEXTA · ReferencePrescription
VENETOCLAX 100MG · TABLET · ORAL
VENCLEXTA · ReferencePrescription
VENETOCLAX 10MG · TABLET · ORAL
VENCLEXTA · ReferencePrescription
VENETOCLAX 50MG · TABLET · ORAL

Approval history

2026-05-20Efficacy · Supplement 32 · standard — Label ↗AP
2026-02-19Efficacy · Supplement 31 · standard — Letter ↗AP
2022-06-15Labeling · Supplement 27 · standard — Letter ↗AP
2021-10-22Labeling · Supplement 26 · standard — Letter ↗AP
2021-10-04Efficacy · Supplement 24 · standard — Label ↗AP
2020-11-19Labeling · Supplement 23 · standard — Letter ↗AP
2020-10-16Efficacy · Supplement 20 · priority — Label ↗AP
2020-10-16Efficacy · Supplement 21 · priority — Label ↗AP
2020-06-12Labeling · Supplement 17 · standard — Letter ↗AP
2020-05-29Labeling · Supplement 18 · standard — Letter ↗AP
2019-07-25Labeling · Supplement 14 · standard — Letter ↗AP
2019-07-25Labeling · Supplement 15 · standard — Letter ↗AP
2019-07-25Labeling · Supplement 11 · standard — Letter ↗AP
2019-05-15Efficacy · Supplement 13 · priority — Label ↗AP
2018-11-21Efficacy · Supplement 9 · priority — Label ↗AP
2018-09-07Labeling · Supplement 10 · standard — Label ↗AP
2018-09-07Efficacy · Supplement 7 · priority — Label ↗AP
2018-06-08Efficacy · Supplement 4 · priority — Label ↗AP
2018-06-08Efficacy · Supplement 5 · priority — Label ↗AP
2017-12-20Efficacy · Supplement 3 · priority — Label ↗AP
2016-04-11Type 1 - New Molecular Entity · Original · priority — Review ↗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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