Last Updated: September 24, 2026

Details for New Drug Application (NDA): 090132


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NDA 090132 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 eight suppliers. Additional details are available on the CARVEDILOL PHOSPHATE profile page.

The generic ingredient in CARVEDILOL PHOSPHATE is carvedilol phosphate. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
Summary for 090132
Tradename:CARVEDILOL PHOSPHATE
Applicant:Sun Pharm Industries
Ingredient:carvedilol phosphate
Patents:0
Pharmacology for NDA: 090132
Mechanism of ActionAdrenergic alpha-Antagonists
Adrenergic beta1-Antagonists
Adrenergic beta2-Antagonists
Suppliers and Packaging for NDA: 090132
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARVEDILOL PHOSPHATE carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 090132 ANDA NorthStar RxLLC 16714-227 16714-227-01 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16714-227-01)
CARVEDILOL PHOSPHATE carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 090132 ANDA NorthStar RxLLC 16714-228 16714-228-01 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16714-228-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Oct 25, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Oct 25, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength40MG
Approval Date:Oct 25, 2017TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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