Details for New Drug Application (NDA): 078165
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NDA 078165 describes CARVEDILOL, which is a drug marketed by Aurobindo Pharma, Beximco Usa, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hikma, Lupin, MLV, Mylan, Pliva Hrvatska Doo, Rubicon, 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 forty-four 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. Ten 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. Ten suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
Summary for 078165
| Tradename: | CARVEDILOL |
| Applicant: | Rubicon |
| Ingredient: | carvedilol |
| Patents: | 0 |
Pharmacology for NDA: 078165
| Mechanism of Action | Adrenergic alpha-Antagonists Adrenergic beta1-Antagonists Adrenergic beta2-Antagonists |
Suppliers and Packaging for NDA: 078165
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL | carvedilol | TABLET;ORAL | 078165 | ANDA | RedPharm Drug, Inc. | 67296-1497 | 67296-1497-1 | 180 TABLET, FILM COATED in 1 BOTTLE (67296-1497-1) |
| CARVEDILOL | carvedilol | TABLET;ORAL | 078165 | ANDA | RedPharm Drug, Inc. | 67296-1497 | 67296-1497-3 | 30 TABLET, FILM COATED in 1 BOTTLE (67296-1497-3) |
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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