Details for New Drug Application (NDA): 078332
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The generic ingredient in CARVEDILOL 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 078332
Tradename: | CARVEDILOL |
Applicant: | Aurobindo Pharma |
Ingredient: | carvedilol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078332
Mechanism of Action | Adrenergic alpha-Antagonists Adrenergic beta1-Antagonists Adrenergic beta2-Antagonists |
Suppliers and Packaging for NDA: 078332
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARVEDILOL | carvedilol | TABLET;ORAL | 078332 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-125 | 43063-125-93 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-125-93) |
CARVEDILOL | carvedilol | TABLET;ORAL | 078332 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-126 | 43063-126-60 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-126-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3.125MG | ||||
Approval Date: | Sep 5, 2007 | TE: | AB | 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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