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FDA ANDA · ANDA206556
BUPROPION HYDROCHLORIDE (XL)
bupropion hydrochloride
Sponsor: INVAGEN PHARMS
APPLICATION
ANDA206556
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-26
LATEST ACTION
2024-02-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 300MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-02-01Labeling · Supplement 18 · standardAP
2024-02-01Labeling · Supplement 16 · standardAP
2020-06-30Labeling · Supplement 14 · standardAP
2017-06-12Labeling · Supplement 3 · standardAP
2016-08-26UNKNOWN · Original · standardAP
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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