Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077475
Company: SANDOZ INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/12/2008 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
08/18/2021 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

06/30/2017 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

06/30/2017 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

11/10/2015 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

11/10/2015 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

08/16/2013 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

02/09/2012 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

11/22/2011 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

06/25/2010 SUPPL-7 REMS-Proposal

Label is not available on this site.

01/25/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/23/2008 SUPPL-1 Labeling

Label is not available on this site.

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 091520 ANCHEN PHARMS
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 INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 206122 SCIEGEN PHARMS INC

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