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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206122
Company: SCIEGEN PHARMS INC

Products on ANDA 206122

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 206122

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/2016	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206122Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/13/2021	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/13/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/30/2017	SUPPL-1	REMS - MODIFIED - D-N-A, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206122

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 INC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	216766	YICHANG HUMANWELL

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