U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 079094
Company: ACTAVIS LABS FL 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 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
03/24/2009 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-36 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/03/2024 SUPPL-35 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/03/2024 SUPPL-33 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/03/2024 SUPPL-30 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

06/30/2017 SUPPL-24 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/14/2015 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

06/14/2015 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/14/2015 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

08/16/2013 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/18/2012 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/27/2010 SUPPL-8 REMS-Proposal

Label is not available on this site.

11/16/2009 SUPPL-5 Labeling-Medication Guide, 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 075914 IMPAX LABS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 077475 SANDOZ
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 206122 SCIEGEN PHARMS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 216766 YICHANG HUMANWELL
Back to Top