Details for New Drug Application (NDA): 077316
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The generic ingredient in CARVEDILOL is carvedilol phosphate. There are thirty-seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
Summary for 077316
Tradename: | CARVEDILOL |
Applicant: | Mylan |
Ingredient: | carvedilol |
Patents: | 0 |
Pharmacology for NDA: 077316
Mechanism of Action | Adrenergic alpha-Antagonists Adrenergic beta1-Antagonists Adrenergic beta2-Antagonists |
Suppliers and Packaging for NDA: 077316
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARVEDILOL | carvedilol | TABLET;ORAL | 077316 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3632 | 0378-3632-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3632-01) |
CARVEDILOL | carvedilol | TABLET;ORAL | 077316 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3632 | 0378-3632-05 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3632-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 3.125MG | ||||
Approval Date: | Sep 5, 2007 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6.25MG | ||||
Approval Date: | Sep 5, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Sep 5, 2007 | TE: | AB | RLD: | No |
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