Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076143
Company: APOTEX INC

• Other Important Information from FDA

Products on ANDA 076143

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	AB	No	No
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076143

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/17/2006	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/07/2024	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
10/10/2023	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
08/22/2022	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/22/2022	SUPPL-25	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/22/2022	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/22/2022	SUPPL-21	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/22/2022	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.
08/22/2022	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
08/22/2022	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
11/20/2014	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
11/20/2014	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/20/2014	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
04/16/2012	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/21/2011	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/08/2010	SUPPL-8	REMS-Proposal		Label is not available on this site.
01/22/2010	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/01/2009	SUPPL-4	Labeling		Label is not available on this site.
01/15/2008	SUPPL-2	Labeling		Label is not available on this site.
10/05/2006	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076143

BUPROPION HYDROCHLORIDE

TABLET;ORAL; 75MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	203013	ALEMBIC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	075584	APNAR PHARMA LP
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	076143	APOTEX INC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	208606	CADILA PHARMS LTD
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	206975	HERITAGE PHARMA
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	207403	MICRO LABS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	203013	ALEMBIC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	075584	APNAR PHARMA LP
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	076143	APOTEX INC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	208606	CADILA PHARMS LTD
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	206975	HERITAGE PHARMA
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	207403	MICRO LABS