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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

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 six 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-two 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 019962
Mechanism of ActionAdrenergic 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 AstraZeneca Pharmaceuticals LP 0186-1088 0186-1088-05 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0186-1088-05)
TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962 NDA AstraZeneca Pharmaceuticals LP 0186-1088 0186-1088-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0186-1088-30)
Paragraph IV (Patent) Challenges for 019962
Tradename Dosage Ingredient NDA Submissiondate
TOPROL-XL TABLET, EXTENDED RELEASE;ORAL metoprolol succinate 019962

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG TARTRATE
Approval Date:Jan 10, 1992TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 100MG TARTRATE
Approval Date:Jan 10, 1992TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 200MG TARTRATE
Approval Date:Jan 10, 1992TE:ABRLD:Yes

Expired US Patents for NDA 019962

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   Start Trial   Start Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-001 Jan 10, 1992   Start Trial   Start Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-003 Jan 10, 1992   Start Trial   Start Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-004 Feb 5, 2001   Start Trial   Start Trial
Toprol TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-004 Feb 5, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
AstraZeneca
Moodys
McKesson
Johnson and Johnson

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