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Last Updated: November 21, 2024

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 seven 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. 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
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:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 7, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:May 7, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength40MG
Approval Date:May 7, 2018TE:ABRLD:No

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