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Details for New Drug Application (NDA): 018063
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NDA 018063 describes CORGARD, which is a drug marketed by Uswm 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. Nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the nadolol profile page.
Summary for 018063
| Tradename: | CORGARD |
| Applicant: | Uswm |
| 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 |
|---|---|---|---|---|---|---|---|
| Uswm | CORGARD | nadolol | TABLET;ORAL | 018063-001 | Approved Prior to Jan 1, 1982 | Try Before You Buy | Try Before You Buy |
| Uswm | CORGARD | nadolol | TABLET;ORAL | 018063-002 | Approved Prior to Jan 1, 1982 | Try Before You Buy | Try Before You Buy |
| Uswm | CORGARD | nadolol | TABLET;ORAL | 018063-003 | Approved Prior to Jan 1, 1982 | Try Before You Buy | Try Before You Buy |
| Uswm | CORGARD | nadolol | TABLET;ORAL | 018063-005 | Oct 28, 1986 | Try Before You Buy | Try Before You Buy |
| Uswm | CORGARD | nadolol | TABLET;ORAL | 018063-002 | Approved Prior to Jan 1, 1982 | Try Before You Buy | Try Before You Buy |
| Uswm | CORGARD | nadolol | TABLET;ORAL | 018063-004 | Approved Prior to Jan 1, 1982 | Try Before You Buy | Try Before You Buy |
| Uswm | CORGARD | nadolol | TABLET;ORAL | 018063-001 | Approved Prior to Jan 1, 1982 | Try Before You Buy | Try Before You Buy |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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