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Generated: January 16, 2019

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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 eleven 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-eight 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
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)

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 019962-001 Jan 10, 1992 ➤ 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
Aralez Pharms TOPROL-XL metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 019962-003 Jan 10, 1992 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Daiichi Sankyo
UBS
US Army
McKesson
Baxter
Fuji
Johnson and Johnson
Julphar

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