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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 218024

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SUNITINIB MALATE (SUNITINIB MALATE)
EQ 12.5MG BASE
Marketing Status: Prescription
Active Ingredient: SUNITINIB MALATE
Proprietary Name: SUNITINIB MALATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 12.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A218024
Product Number: 001
Approval Date: Oct 24, 2023
Applicant Holder Full Name: NATCO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
SUNITINIB MALATE (SUNITINIB MALATE)
EQ 25MG BASE
Marketing Status: Prescription
Active Ingredient: SUNITINIB MALATE
Proprietary Name: SUNITINIB MALATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A218024
Product Number: 002
Approval Date: Oct 24, 2023
Applicant Holder Full Name: NATCO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
SUNITINIB MALATE (SUNITINIB MALATE)
EQ 37.5MG BASE
Marketing Status: Prescription
Active Ingredient: SUNITINIB MALATE
Proprietary Name: SUNITINIB MALATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 37.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A218024
Product Number: 003
Approval Date: Oct 24, 2023
Applicant Holder Full Name: NATCO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
SUNITINIB MALATE (SUNITINIB MALATE)
EQ 50MG BASE
Marketing Status: Prescription
Active Ingredient: SUNITINIB MALATE
Proprietary Name: SUNITINIB MALATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A218024
Product Number: 004
Approval Date: Oct 24, 2023
Applicant Holder Full Name: NATCO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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