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Details for New Drug Application (NDA): 020297
NDA 020297 describes COREG, which is a drug marketed by Smithkline Beecham and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the COREG profile page.
The generic ingredient in COREG is carvedilol phosphate. There are thirty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
The generic ingredient in COREG is carvedilol phosphate. There are thirty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
Summary for 020297
| Tradename: | COREG |
| Applicant: | Smithkline Beecham |
| Ingredient: | carvedilol |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020297
| Mechanism of Action | Adrenergic alpha-Antagonists Adrenergic beta1-Antagonists Adrenergic beta2-Antagonists |
Suppliers and Packaging for NDA: 020297
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COREG | carvedilol | TABLET;ORAL | 020297 | NDA | GlaxoSmithKline LLC | 0007-4139 | 0007-4139-20 | 100 TABLET, FILM COATED in 1 BOTTLE (0007-4139-20) |
| COREG | carvedilol | TABLET;ORAL | 020297 | NDA | GlaxoSmithKline LLC | 0007-4140 | 0007-4140-20 | 100 TABLET, FILM COATED in 1 BOTTLE (0007-4140-20) |
Paragraph IV (Patent) Challenges for 020297
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| COREG | TABLET;ORAL | carvedilol | 020297 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Sep 14, 1995 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Sep 14, 1995 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6.25MG | ||||
| Approval Date: | Sep 14, 1995 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020297
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Smithkline Beecham | COREG | carvedilol | TABLET;ORAL | 020297-002 | Sep 14, 1995 | Start Trial | Start Trial |
| Smithkline Beecham | COREG | carvedilol | TABLET;ORAL | 020297-001 | Sep 14, 1995 | Start Trial | Start Trial |
| Smithkline Beecham | COREG | carvedilol | TABLET;ORAL | 020297-004 | May 29, 1997 | Start Trial | Start Trial |
| Smithkline Beecham | COREG | carvedilol | TABLET;ORAL | 020297-003 | Sep 14, 1995 | Start Trial | Start Trial |
| Smithkline Beecham | COREG | carvedilol | TABLET;ORAL | 020297-002 | Sep 14, 1995 | Start Trial | Start Trial |
| Smithkline Beecham | COREG | carvedilol | TABLET;ORAL | 020297-001 | Sep 14, 1995 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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