Details for New Drug Application (NDA): 019962
✉ Email this page to a colleague
NDA 019962 describes TOPROL-XL, which is a drug marketed by Toprol and is included in one NDA. It is available from three suppliers. Additional details are available on the TOPROL-XL profile page.
The generic ingredient in TOPROL-XL is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
The generic ingredient in TOPROL-XL is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-six 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 |
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 | Aphena Pharma Solutions - Tennessee, LLC | 67544-282 | 67544-282-51 | 6000 TABLET, EXTENDED RELEASE in 1 BOTTLE (67544-282-51) |
| TOPROL-XL | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 019962 | NDA | Aphena Pharma Solutions - Tennessee, LLC | 67544-491 | 67544-491-45 | 45 TABLET, EXTENDED RELEASE in 1 BOTTLE (67544-491-45) |
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 | 019962-001 | Jan 10, 1992 | 4,927,640*PED | ⤷ Try for Free |
| Toprol | TOPROL-XL | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 019962-003 | Jan 10, 1992 | 5,001,161*PED | ⤷ Try for Free |
| Toprol | TOPROL-XL | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 019962-004 | Feb 5, 2001 | 4,927,640*PED | ⤷ Try for Free |
| Toprol | TOPROL-XL | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 019962-003 | Jan 10, 1992 | 3,876,802 | ⤷ Try for Free |
| Toprol | TOPROL-XL | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 019962-002 | Jan 10, 1992 | 5,246,714*PED | ⤷ Try for Free |
| Toprol | TOPROL-XL | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 019962-002 | Jan 10, 1992 | 4,957,745*PED | ⤷ Try for Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Showing 1 to 6 of 6 entries
Complete Access Available with Subscription
