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FDA NDA · NDA200063

CONTRAVE EXTENDED-RELEASE

naltrexone hydrochloride and bupropion hydrochloride

Sponsor: AZURITY

APPLICATION
NDA200063
TYPE
NDA
ORIGINAL APPROVAL
2014-09-10
LATEST ACTION
2025-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

CONTRAVE · ReferencePrescription
BUPROPION HYDROCHLORIDE 90MG, NALTREXONE HYDROCHLORIDE 8MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-11-05Labeling · Supplement 26 · 901 required — Letter ↗AP
2025-11-05Labeling · Supplement 24 · standard — Letter ↗AP
2024-05-07Labeling · Supplement 22 · 901 required — Letter ↗AP
2023-11-30Labeling · Supplement 21 · standard — Label ↗AP
2021-04-14Labeling · Supplement 20 · standard — Letter ↗AP
2020-08-04Labeling · Supplement 15 · standard — Letter ↗AP
2018-06-13Labeling · Supplement 13 · standard — Letter ↗AP
2017-05-04Labeling · Supplement 9 · standard — Label ↗AP
2017-03-10Labeling · Supplement 6 · standard — Label ↗AP
2017-01-27Manufacturing (CMC) · Supplement 5 · standardAP
2017-01-06Manufacturing (CMC) · Supplement 3 · standardAP
2015-06-08Manufacturing (CMC) · Supplement 2 · standardAP
2015-03-16Manufacturing (CMC) · Supplement 1 · standardAP
2014-09-10Type 4 - New Combination · Original · standard — Label ↗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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