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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076143
Company: APOTEX INC
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
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
08/22/2022 SUPPL-26 Labeling-Package Insert, Labeling-Medication Guide

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-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/22/2022 SUPPL-19 Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-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-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

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.

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 PHARMS LTD
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 207389 INVAGEN PHARMS
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 PHARMS LTD
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 207389 INVAGEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 207403 MICRO LABS
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