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FDA NDA · NDA022497

BUPROPION HCL ER (XL)

bupropion hcl er

Sponsor: TWI PHARMS

APPLICATION
NDA022497
TYPE
NDA
ORIGINAL APPROVAL
2011-11-10
LATEST ACTION
2025-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

FORFIVO XL · ReferencePrescription
BUPROPION HYDROCHLORIDE 450MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-11-05Labeling · Supplement 18 · standard — Letter ↗AP
2024-05-07Labeling · Supplement 15 · standard — Letter ↗AP
2019-12-10Labeling · Supplement 8 · standard — Letter ↗AP
2017-05-04Labeling · Supplement 4 · standard — Label ↗AP
2016-08-30Labeling · Supplement 3 · standard — Label ↗AP
2014-07-17Labeling · Supplement 2 · 901 required — Label ↗AP
2011-11-10Type 3 - New Dosage Form · Original · standard — 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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