Product Details for ANDA 216916
METOPROLOL SUCCINATE (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: METOPROLOL SUCCINATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 25MG TARTRATE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216916
Product Number: 001
Approval Date: Jun 12, 2023
Applicant Holder Full Name: GRANULES INDIA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
Proprietary Name: METOPROLOL SUCCINATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 25MG TARTRATE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216916
Product Number: 001
Approval Date: Jun 12, 2023
Applicant Holder Full Name: GRANULES INDIA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 50MG TARTRATE
Marketing Status: Prescription
Active Ingredient: METOPROLOL SUCCINATE
Proprietary Name: METOPROLOL SUCCINATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 50MG TARTRATE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216916
Product Number: 002
Approval Date: Jun 12, 2023
Applicant Holder Full Name: GRANULES INDIA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
Proprietary Name: METOPROLOL SUCCINATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 50MG TARTRATE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216916
Product Number: 002
Approval Date: Jun 12, 2023
Applicant Holder Full Name: GRANULES INDIA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 100MG TARTRATE
Marketing Status: Prescription
Active Ingredient: METOPROLOL SUCCINATE
Proprietary Name: METOPROLOL SUCCINATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 100MG TARTRATE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216916
Product Number: 003
Approval Date: Jun 12, 2023
Applicant Holder Full Name: GRANULES INDIA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
Proprietary Name: METOPROLOL SUCCINATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 100MG TARTRATE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216916
Product Number: 003
Approval Date: Jun 12, 2023
Applicant Holder Full Name: GRANULES INDIA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 200MG TARTRATE
Marketing Status: Prescription
Active Ingredient: METOPROLOL SUCCINATE
Proprietary Name: METOPROLOL SUCCINATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 200MG TARTRATE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216916
Product Number: 004
Approval Date: Jun 12, 2023
Applicant Holder Full Name: GRANULES INDIA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: METOPROLOL SUCCINATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 200MG TARTRATE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216916
Product Number: 004
Approval Date: Jun 12, 2023
Applicant Holder Full Name: GRANULES INDIA LTD
Marketing Status: Prescription
Patent and Exclusivity Information