Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075913
Company: IMPAX LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 No No
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG 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
01/28/2004 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75913ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075913_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/24/2014 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

10/21/2011 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

10/21/2011 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

08/02/2010 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

05/24/2010 SUPPL-18 Labeling-Medication Guide

Label is not available on this site.

05/10/2010 SUPPL-17 REMS-Proposal

Label is not available on this site.

04/05/2010 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

03/22/2004 SUPPL-3 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075913_S003_AP.pdf
03/22/2004 SUPPL-2 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075913_S002_AP.pdf
03/22/2004 SUPPL-1 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075913_S001_AP.pdf

BUPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 079095 ACTAVIS LABS FL INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 091459 ANCHEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075913 IMPAX LABS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 206674 INVAGEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202774 JUBILANT GENERICS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 090325 MYLAN
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202304 PRINSTON INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075932 SANDOZ
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 205794 SCIEGEN PHARMS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 078866 SUN PHARM
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 203969 TORRENT
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 077455 WATSON LABS INC
WELLBUTRIN SR BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 020358 GLAXOSMITHKLINE

TABLET, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB1

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 AB1 079095 ACTAVIS LABS FL INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 091459 ANCHEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075913 IMPAX LABS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 206674 INVAGEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202774 JUBILANT GENERICS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 090325 MYLAN
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202304 PRINSTON INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075932 SANDOZ
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 205794 SCIEGEN PHARMS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 078866 SUN PHARM
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 203969 TORRENT
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 077455 WATSON LABS INC
WELLBUTRIN SR BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 020358 GLAXOSMITHKLINE

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English