Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090693
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription AB3 No No
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription AB3 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
04/06/2017 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
01/24/2019 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert

Label is not available on this site.

BUPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB3

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 AB3 210497 ACCORD HLTHCARE
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 077715 ACTAVIS LABS FL INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 207224 ANBISON LAB
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 077284 ANCHEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 211020 GRAVITI PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 077415 IMPAX LABS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 206556 INVAGEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 207459 JUBILANT GENERICS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 090693 LUPIN LTD
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 207479 SCIEGEN PHARMS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 208652 SINOTHERAPEUTICS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 200695 SUN PHARM
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 210081 TWI PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 077285 WATSON LABS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 202189 WOCKHARDT LTD
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 210015 YICHANG HUMANWELL
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 201567 ZYDUS PHARMS
WELLBUTRIN XL BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB3 021515 VALEANT INTL

TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 210497 ACCORD HLTHCARE
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 207224 ANBISON LAB
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 077284 ANCHEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 211020 GRAVITI PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 206556 INVAGEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 207459 JUBILANT GENERICS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 090693 LUPIN LTD
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 090942 MYLAN
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 207479 SCIEGEN PHARMS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 208652 SINOTHERAPEUTICS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 210081 TWI PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 077285 WATSON LABS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 210015 YICHANG HUMANWELL
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 201567 ZYDUS PHARMS
WELLBUTRIN XL BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB3 021515 VALEANT INTL

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