Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Harvard Business School
Merck
Cerilliant
Mallinckrodt
Citi
Moodys
UBS
Julphar

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019962

« Back to Dashboard

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

The generic ingredient in TOPROL-XL is metoprolol succinate. There are fifty-nine drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
Summary for 019962
Tradename:TOPROL-XL
Applicant:Aralez Pharms
Ingredient:metoprolol succinate
Patents:0
Therapeutic Class:Cardiovascular Agents
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 N 0186-1088-05
TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962 NDA AstraZeneca Pharmaceuticals LP 0186-1088 N 0186-1088-39

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
Aralez Pharms TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-004 Feb 5, 2001 ➤ Sign Up ➤ Sign Up
Aralez Pharms TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-004 Feb 5, 2001 ➤ Sign Up ➤ Sign Up
Aralez Pharms TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-002 Jan 10, 1992 ➤ Sign Up ➤ Sign Up
Aralez Pharms TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-004 Feb 5, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
AstraZeneca
McKesson
Accenture
US Army
US Department of Justice
Baxter
Julphar
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.