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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211347
Company: YICHANG HUMANWELL
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
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG 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
10/16/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2023 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

06/23/2022 SUPPL-9 Labeling-Container/Carton Labels

Label is not available on this site.

12/21/2020 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/28/2020 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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 216800 ANNORA PHARMA
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075932 EPIC PHARMA LLC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 218385 GRANULES
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 202304 PRINSTON INC
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 211347 YICHANG HUMANWELL
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 216800 ANNORA PHARMA
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075932 EPIC PHARMA LLC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 218385 GRANULES
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 202304 PRINSTON INC
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 211347 YICHANG HUMANWELL
WELLBUTRIN SR BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 020358 GLAXOSMITHKLINE

TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 079095 ACTAVIS LABS FL INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 216800 ANNORA PHARMA
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075932 EPIC PHARMA LLC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 218385 GRANULES
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202304 PRINSTON INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 205794 SCIEGEN PHARMS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 211347 YICHANG HUMANWELL
WELLBUTRIN SR BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 020358 GLAXOSMITHKLINE
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