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FDA ANDA · ANDA211200
BUPROPION HYDROCHLORIDE XL
bupropion hydrochloride
Sponsor: ZHEJIANG JUTAI PHARM
APPLICATION
ANDA211200
TYPE
ANDA
ORIGINAL APPROVAL
2019-09-05
LATEST ACTION
2024-12-19
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
2024-12-19Manufacturing (CMC) · Supplement 7 · unknownAP
2024-10-01Labeling · Supplement 8 · standardAP
2024-10-01Labeling · Supplement 6 · standardAP
2024-10-01Labeling · Supplement 3 · standardAP
2019-09-05UNKNOWN · 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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