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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203028
Company: PHARMADAX INC

Products on ANDA 203028

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203028

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/2020	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
09/26/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/26/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203028

METOPROLOL SUCCINATE

TABLET, EXTENDED RELEASE;ORAL; EQ 25MG TARTRATE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204161	ACTAVIS ELIZABETH
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211143	ALKEM LABS LTD
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090617	DR REDDYS LABS LTD
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216916	GRANULES
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205541	HETERO LABS LTD III
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202033	MYLAN PHARMS INC
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204106	NOVAST LABS
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203028	PHARMADAX INC
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207206	VISUM PHARM
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090615	WOCKHARDT
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213854	YICHANG HUMANWELL
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203894	ZYDUS PHARMS
TOPROL-XL	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	019962	TOPROL

TABLET, EXTENDED RELEASE;ORAL; EQ 50MG TARTRATE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204161	ACTAVIS ELIZABETH
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076862	ACTAVIS LABS FL INC
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211143	ALKEM LABS LTD
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207465	CIPLA
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090617	DR REDDYS LABS LTD
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216916	GRANULES
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205541	HETERO LABS LTD III
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202033	MYLAN PHARMS INC
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204106	NOVAST LABS
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203028	PHARMADAX INC
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214004	SUNSHINE
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207206	VISUM PHARM
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090615	WOCKHARDT
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213854	YICHANG HUMANWELL
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203894	ZYDUS PHARMS
TOPROL-XL	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	019962	TOPROL

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