Product Details for NDA 210428
KAPSPARGO SPRINKLE (METOPROLOL SUCCINATE)
EQ 25MG TARTRATE
Marketing Status: Prescription
EQ 50MG TARTRATE
Marketing Status: Prescription
EQ 100MG TARTRATE
Marketing Status: Prescription
EQ 200MG TARTRATE
Marketing Status: Prescription
EQ 25MG TARTRATE
Marketing Status: Prescription
Active Ingredient: METOPROLOL SUCCINATE
Proprietary Name: KAPSPARGO SPRINKLE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 25MG TARTRATE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N210428
Product Number: 001
Approval Date: Jan 26, 2018
Applicant Holder Full Name: SUN PHARMA INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
KAPSPARGO SPRINKLE (METOPROLOL SUCCINATE)
Proprietary Name: KAPSPARGO SPRINKLE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 25MG TARTRATE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N210428
Product Number: 001
Approval Date: Jan 26, 2018
Applicant Holder Full Name: SUN PHARMA INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 50MG TARTRATE
Marketing Status: Prescription
Active Ingredient: METOPROLOL SUCCINATE
Proprietary Name: KAPSPARGO SPRINKLE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 50MG TARTRATE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N210428
Product Number: 002
Approval Date: Jan 26, 2018
Applicant Holder Full Name: SUN PHARMA INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
KAPSPARGO SPRINKLE (METOPROLOL SUCCINATE)
Proprietary Name: KAPSPARGO SPRINKLE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 50MG TARTRATE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N210428
Product Number: 002
Approval Date: Jan 26, 2018
Applicant Holder Full Name: SUN PHARMA INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 100MG TARTRATE
Marketing Status: Prescription
Active Ingredient: METOPROLOL SUCCINATE
Proprietary Name: KAPSPARGO SPRINKLE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 100MG TARTRATE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N210428
Product Number: 003
Approval Date: Jan 26, 2018
Applicant Holder Full Name: SUN PHARMA INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
KAPSPARGO SPRINKLE (METOPROLOL SUCCINATE)
Proprietary Name: KAPSPARGO SPRINKLE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 100MG TARTRATE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N210428
Product Number: 003
Approval Date: Jan 26, 2018
Applicant Holder Full Name: SUN PHARMA INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 200MG TARTRATE
Marketing Status: Prescription
Active Ingredient: METOPROLOL SUCCINATE
Proprietary Name: KAPSPARGO SPRINKLE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 200MG TARTRATE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N210428
Product Number: 004
Approval Date: Jan 26, 2018
Applicant Holder Full Name: SUN PHARMA INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: KAPSPARGO SPRINKLE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 200MG TARTRATE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N210428
Product Number: 004
Approval Date: Jan 26, 2018
Applicant Holder Full Name: SUN PHARMA INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information