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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 Astrazeneca 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-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.

Summary for NDA: 019962

Tradename:
TOPROL-XL
Applicant:
Astrazeneca 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 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:No

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
Astrazeneca Pharms
TOPROL-XL
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL019962-003Jan 10, 19924,927,640*PED► subscribe
Astrazeneca Pharms
TOPROL-XL
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL019962-001Jan 10, 19925,081,154*PED► subscribe
Astrazeneca Pharms
TOPROL-XL
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL019962-003Jan 10, 19924,957,745*PED► subscribe
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