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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Dow
Fish and Richardson
AstraZeneca
Federal Trade Commission
Boehringer Ingelheim
Mallinckrodt
Harvard Business School
Novartis
Merck

Generated: November 23, 2017

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 Aralez Pharms and is included in one NDA. It is available from eight suppliers. Additional details are available on the TOPROL-XL profile page.

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

Summary for 019962

Tradename:
1
Applicant:
1
Ingredient:
1
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 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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book 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;ORAL019962-002Jan 10, 1992► Subscribe► Subscribe
Aralez Pharms
TOPROL-XL
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL019962-002Jan 10, 1992► Subscribe► Subscribe
Aralez Pharms
TOPROL-XL
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL019962-001Jan 10, 1992► Subscribe► Subscribe
Aralez Pharms
TOPROL-XL
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL019962-004Feb 5, 2001► Subscribe► Subscribe
Aralez Pharms
TOPROL-XL
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL019962-003Jan 10, 1992► Subscribe► Subscribe
Aralez Pharms
TOPROL-XL
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL019962-003Jan 10, 1992► Subscribe► Subscribe
Aralez Pharms
TOPROL-XL
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL019962-004Feb 5, 2001► Subscribe► Subscribe
Aralez Pharms
TOPROL-XL
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL019962-004Feb 5, 2001► Subscribe► Subscribe
Aralez Pharms
TOPROL-XL
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL019962-002Jan 10, 1992► Subscribe► Subscribe
Aralez Pharms
TOPROL-XL
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL019962-003Jan 10, 1992► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
Teva
Federal Trade Commission
Queensland Health
Farmers Insurance
Moodys
Merck
Harvard Business School
Novartis

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.

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