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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216766
Company: YICHANG HUMANWELL

Products on ANDA 216766

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216766

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/09/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2025	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/17/2025	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/07/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/12/2024	SUPPL-1	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216766

BUPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	079094	ACTAVIS LABS FL INC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	075914	IMPAX LABS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	077475	SANDOZ
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	206122	SCIEGEN PHARMS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	216766	YICHANG HUMANWELL

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