Details for New Drug Application (NDA): 204717
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The generic ingredient in CARVEDILOL PHOSPHATE 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 204717
Tradename: | CARVEDILOL PHOSPHATE |
Applicant: | Impax Labs Inc |
Ingredient: | carvedilol phosphate |
Patents: | 0 |
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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