Details for New Drug Application (NDA): 019962

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NDA 019962 describes TOPROL-XL, which is a drug marketed by Toprol and is included in one NDA. It is available from five 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-nine suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.

Summary for 019962

Tradename:	TOPROL-XL
Applicant:	Toprol
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 AUTHORIZED GENERIC	New American Therapeutics	50816-025	50816-025-02	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50816-025-02)
TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962	NDA AUTHORIZED GENERIC	New American Therapeutics	50816-025	50816-025-03	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50816-025-03)

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-002	Jan 10, 1992	⤷ Sign Up	⤷ Sign Up
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-002	Jan 10, 1992	⤷ Sign Up	⤷ Sign Up
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-001	Jan 10, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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