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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206975
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription AB No No
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription AB 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
08/19/2016 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
11/11/2020 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/11/2020 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

11/11/2020 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

BUPROPION HYDROCHLORIDE

TABLET;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 203013 ALEMBIC PHARMS LTD
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 075584 APNAR PHARMA LP
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 076143 APOTEX INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 208606 CADILA PHARMS LTD
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 206975 HERITAGE PHARMA
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 207389 INVAGEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 207403 MICRO LABS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 203013 ALEMBIC PHARMS LTD
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 075584 APNAR PHARMA LP
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 076143 APOTEX INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 208606 CADILA PHARMS LTD
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 206975 HERITAGE PHARMA
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 207389 INVAGEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 207403 MICRO LABS
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