Details for New Drug Application (NDA): 019962
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The generic ingredient in TOPROL-XL is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-nine 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 Action | Adrenergic 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 AUTHORIZED GENERIC | A-S Medication Solutions | 50090-3808 | 50090-3808-0 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3808-0) |
TOPROL-XL | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 019962 | NDA AUTHORIZED GENERIC | A-S Medication Solutions | 50090-3808 | 50090-3808-1 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-3808-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 50MG TARTRATE | ||||
Approval Date: | Jan 10, 1992 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 100MG TARTRATE | ||||
Approval Date: | Jan 10, 1992 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 200MG TARTRATE | ||||
Approval Date: | Jan 10, 1992 | TE: | AB | RLD: | 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 | 019962-003 | Jan 10, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Toprol | TOPROL-XL | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 019962-001 | Jan 10, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Toprol | TOPROL-XL | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 019962-003 | Jan 10, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Toprol | TOPROL-XL | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 019962-002 | Jan 10, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Toprol | TOPROL-XL | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 019962-002 | Jan 10, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Toprol | 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 |
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