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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205541

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METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
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: A205541
Product Number: 001
Approval Date: Nov 6, 2020
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status:  Prescription
Patent and Exclusivity Information
METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
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: A205541
Product Number: 002
Approval Date: Nov 6, 2020
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status:  Prescription
Patent and Exclusivity Information
METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
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: A205541
Product Number: 003
Approval Date: Nov 6, 2020
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status:  Prescription
Patent and Exclusivity Information
METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
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: A205541
Product Number: 004
Approval Date: Nov 6, 2020
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status:  Prescription
Patent and Exclusivity Information
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