Details for New Drug Application (NDA): 078251
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NDA 078251 describes CARVEDILOL, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Glenmark Pharms Ltd, Hikma, Lupin, MLV, Pharmobedient, Pliva Hrvatska Doo, Regcon Holdings, Rising, Rubicon Research, Sandoz, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Taro, Teva, Zydus Pharms Usa Inc, Impax Labs Inc, and Sun Pharm Industries, and is included in nineteen NDAs. It is available from thirty-six suppliers. Additional details are available on the CARVEDILOL profile page.
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.
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 078251
| Tradename: | CARVEDILOL |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | carvedilol |
| Patents: | 0 |
Pharmacology for NDA: 078251
| Mechanism of Action | Adrenergic alpha-Antagonists Adrenergic beta1-Antagonists Adrenergic beta2-Antagonists |
Suppliers and Packaging for NDA: 078251
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL | carvedilol | TABLET;ORAL | 078251 | ANDA | Major Pharmaceuticals | 0904-7305 | 0904-7305-61 | 100 BLISTER PACK in 1 CARTON (0904-7305-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| CARVEDILOL | carvedilol | TABLET;ORAL | 078251 | ANDA | Major Pharmaceuticals | 0904-7306 | 0904-7306-61 | 100 BLISTER PACK in 1 CARTON (0904-7306-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
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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