An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202304
Company: PRINSTON INC

Products on ANDA 202304

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202304

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/26/2015	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
01/29/2025	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
02/15/2024	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/09/2022	SUPPL-14	Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
03/12/2021	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/12/2021	SUPPL-11	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/14/2017	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/14/2017	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/14/2017	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202304

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	090325	AUROBINDO PHARMA USA
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	207874	IPCA LABS LTD
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
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	211347	YICHANG HUMANWELL
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	220529	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	090325	AUROBINDO PHARMA USA
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	207874	IPCA LABS LTD
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
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	211347	YICHANG HUMANWELL
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	220529	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	090325	AUROBINDO PHARMA USA
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	207874	IPCA LABS LTD
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
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	211347	YICHANG HUMANWELL
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	220529	YICHANG HUMANWELL
WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB1	020358	GLAXOSMITHKLINE

Top