U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078866
Company: SUN PHARM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Discontinued None 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
04/06/2010 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
06/21/2023 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
06/21/2023 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
06/21/2023 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
06/21/2023 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
04/14/2017 SUPPL-12 Labeling

Label is not available on this site.
04/14/2017 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/20/2014 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/20/2014 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified

Label is not available on this site.
07/28/2013 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
Back to Top