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Details for New Drug Application (NDA): 018063
NDA 018063 describes CORGARD, which is a drug marketed by Us Worldmeds Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the CORGARD profile page.
The generic ingredient in CORGARD is nadolol. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the nadolol profile page.
The generic ingredient in CORGARD is nadolol. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the nadolol profile page.
Summary for 018063
| Tradename: | CORGARD |
| Applicant: | Us Worldmeds Llc |
| Ingredient: | nadolol |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018063
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 018063
Suppliers and Packaging for NDA: 018063
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CORGARD | nadolol | TABLET;ORAL | 018063 | NDA | US WorldMeds, LLC | 27505-100 | 27505-100-01 | 100 TABLET in 1 BOTTLE (27505-100-01) |
| CORGARD | nadolol | TABLET;ORAL | 018063 | NDA | US WorldMeds, LLC | 27505-101 | 27505-101-01 | 100 TABLET in 1 BOTTLE (27505-101-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 120MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Expired US Patents for NDA 018063
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Us Worldmeds Llc | CORGARD | nadolol | TABLET;ORAL | 018063-003 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Us Worldmeds Llc | CORGARD | nadolol | TABLET;ORAL | 018063-005 | Oct 28, 1986 | Start Trial | Start Trial |
| Us Worldmeds Llc | CORGARD | nadolol | TABLET;ORAL | 018063-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Us Worldmeds Llc | CORGARD | nadolol | TABLET;ORAL | 018063-004 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Us Worldmeds Llc | CORGARD | nadolol | TABLET;ORAL | 018063-002 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Us Worldmeds Llc | CORGARD | nadolol | TABLET;ORAL | 018063-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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