Details for New Drug Application (NDA): 204717
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NDA 204717 describes CARVEDILOL PHOSPHATE, which is a drug marketed by Impax Labs Inc and Sun Pharm Industries and is included in two NDAs. It is available from five suppliers. Additional details are available on the CARVEDILOL PHOSPHATE profile page.
The generic ingredient in CARVEDILOL PHOSPHATE is carvedilol phosphate. There are thirty-seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
The generic ingredient in CARVEDILOL PHOSPHATE is carvedilol phosphate. There are thirty-seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
Summary for 204717
| Tradename: | CARVEDILOL PHOSPHATE |
| Applicant: | Impax Labs Inc |
| Ingredient: | carvedilol phosphate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204717
| Mechanism of Action | Adrenergic alpha-Antagonists Adrenergic beta1-Antagonists Adrenergic beta2-Antagonists |
Suppliers and Packaging for NDA: 204717
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL PHOSPHATE | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 204717 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1248 | 0115-1248-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-01) |
| CARVEDILOL PHOSPHATE | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 204717 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1248 | 0115-1248-03 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | May 7, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 20MG | ||||
| Approval Date: | May 7, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 40MG | ||||
| Approval Date: | May 7, 2018 | TE: | AB | RLD: | No | ||||
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