Details for New Drug Application (NDA): 019962

NDA 019962 describes TOPROL-XL, which is a drug marketed by Melinta Therap and is included in one NDA. It is available from three suppliers. Additional details are available on the TOPROL-XL profile page.

The generic ingredient in TOPROL-XL is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.

Summary for 019962

Tradename:	TOPROL-XL
Applicant:	Melinta Therap
Ingredient:	metoprolol succinate
Patents:	0

Pharmacology for NDA: 019962

Mechanism of Action

Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 019962

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962	NDA	Melinta Therapeutics, LLC	70842-110	70842-110-02	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70842-110-02)
TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962	NDA	Melinta Therapeutics, LLC	70842-111	70842-111-02	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70842-111-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 50MG TARTRATE
Approval Date:	Jan 10, 1992	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 100MG TARTRATE
Approval Date:	Jan 10, 1992	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 200MG TARTRATE
Approval Date:	Jan 10, 1992	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019962

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Melinta Therap	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-001	Jan 10, 1992	4,927,640*PED
Melinta Therap	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992	5,001,161*PED
Melinta Therap	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-004	Feb 5, 2001	4,927,640*PED
Melinta Therap	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992	3,876,802
Melinta Therap	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-002	Jan 10, 1992	5,246,714*PED
Melinta Therap	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-002	Jan 10, 1992	4,957,745*PED
Melinta Therap	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-004	Feb 5, 2001	5,246,714*PED

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