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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075914
Company: IMPAX LABS
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
05/27/2004 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
06/06/2022 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

06/30/2017 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

01/04/2016 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

09/24/2014 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

09/24/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

04/10/2012 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

06/24/2011 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

05/13/2010 SUPPL-13 REMS-Proposal

Label is not available on this site.

01/25/2010 SUPPL-12 Labeling-Package Insert

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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