Details for New Drug Application (NDA): 022012
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NDA 022012 describes COREG CR, which is a drug marketed by Waylis Therap and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the COREG CR profile page.
The generic ingredient in COREG CR is carvedilol phosphate. There are thirty-seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
The generic ingredient in COREG CR is carvedilol phosphate. There are thirty-seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
Summary for 022012
| Tradename: | COREG CR |
| Applicant: | Waylis Therap |
| Ingredient: | carvedilol phosphate |
| Patents: | 1 |
Pharmacology for NDA: 022012
| Mechanism of Action | Adrenergic alpha-Antagonists Adrenergic beta1-Antagonists Adrenergic beta2-Antagonists |
Suppliers and Packaging for NDA: 022012
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012 | NDA | Waylis Therapeutics LLC | 80725-383 | 80725-383-13 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80725-383-13) |
| COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012 | NDA | Waylis Therapeutics LLC | 80725-385 | 80725-385-13 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80725-385-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 20, 2006 | TE: | AB | RLD: | Yes | ||||
| Patent: | 8,101,209*PED | Patent Expiration: | Mar 11, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 20MG | ||||
| Approval Date: | Oct 20, 2006 | TE: | AB | RLD: | Yes | ||||
| Patent: | 8,101,209*PED | Patent Expiration: | Mar 11, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 40MG | ||||
| Approval Date: | Oct 20, 2006 | TE: | AB | RLD: | Yes | ||||
| Patent: | 8,101,209*PED | Patent Expiration: | Mar 11, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 022012
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Waylis Therap | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-003 | Oct 20, 2006 | 5,760,069*PED | ⤷ Start Trial |
| Waylis Therap | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-004 | Oct 20, 2006 | 5,760,069*PED | ⤷ Start Trial |
| Waylis Therap | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-002 | Oct 20, 2006 | 7,268,156*PED | ⤷ Start Trial |
| Waylis Therap | COREG CR | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 022012-001 | Oct 20, 2006 | 4,503,067*PED | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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