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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206674
Company: INVAGEN PHARMS
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
02/09/2016 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206674Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2021 SUPPL-13 Labeling-Patient Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/04/2021 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/04/2021 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/17/2017 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

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