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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206122
Company: SCIEGEN PHARMS 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 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
08/17/2016 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206122Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2021 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/13/2021 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/13/2021 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

06/30/2017 SUPPL-1 REMS - MODIFIED - D-N-A, 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 091520 ANCHEN PHARMS
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 INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 206122 SCIEGEN PHARMS INC
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