Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076711
Company: IMPAX LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 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
12/03/2004 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
09/29/2015 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

09/29/2015 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

09/29/2015 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

09/29/2015 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

02/21/2012 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

02/21/2012 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

08/18/2010 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/08/2010 SUPPL-11 REMS-Proposal

Label is not available on this site.

01/27/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/16/2008 SUPPL-7 Labeling

Label is not available on this site.

10/05/2006 SUPPL-5 Labeling

Label is not available on this site.

02/14/2006 SUPPL-3 Labeling

Label is not available on this site.

BUPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 079095 ACTAVIS LABS FL INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 091459 ANCHEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 076711 IMPAX LABS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 206674 INVAGEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202774 JUBILANT GENERICS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 090325 MYLAN
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202304 PRINSTON INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075932 SANDOZ
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 205794 SCIEGEN PHARMS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 078866 SUN PHARM
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 203969 TORRENT
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 077455 WATSON LABS INC
WELLBUTRIN SR BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 020358 GLAXOSMITHKLINE

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