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FDA ANDA · ANDA207479
BUPROPION HYDROCHLORIDE (XL)
bupropion hydrochloride
Sponsor: SCIEGEN PHARMS
APPLICATION
ANDA207479
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-12
LATEST ACTION
2020-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 300MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2020-06-30Labeling · Supplement 2 · standardAP
2020-06-30Labeling · Supplement 10 · standardAP
2017-04-12UNKNOWN · 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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