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Drugs@FDA: FDA-Approved Drugs

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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
02/15/2024	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/09/2022	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Medication Guide		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-Container/Carton Labels, Labeling-Medication Guide, 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	075932	EPIC PHARMA LLC
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	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	078866	SUN PHARM
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	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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