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Details for New Drug Application (NDA): 020297
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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