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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090132

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CARVEDILOL PHOSPHATE (CARVEDILOL PHOSPHATE)
10MG
Marketing Status: Prescription
Active Ingredient: CARVEDILOL PHOSPHATE
Proprietary Name: CARVEDILOL PHOSPHATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090132
Product Number: 001
Approval Date: Oct 25, 2017
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
CARVEDILOL PHOSPHATE (CARVEDILOL PHOSPHATE)
20MG
Marketing Status: Prescription
Active Ingredient: CARVEDILOL PHOSPHATE
Proprietary Name: CARVEDILOL PHOSPHATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090132
Product Number: 002
Approval Date: Oct 25, 2017
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
CARVEDILOL PHOSPHATE (CARVEDILOL PHOSPHATE)
40MG
Marketing Status: Prescription
Active Ingredient: CARVEDILOL PHOSPHATE
Proprietary Name: CARVEDILOL PHOSPHATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090132
Product Number: 003
Approval Date: Oct 25, 2017
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
CARVEDILOL PHOSPHATE (CARVEDILOL PHOSPHATE)
80MG
Marketing Status: Prescription
Active Ingredient: CARVEDILOL PHOSPHATE
Proprietary Name: CARVEDILOL PHOSPHATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090132
Product Number: 004
Approval Date: Oct 25, 2017
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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