Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076704

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METOPROLOL TARTRATE (METOPROLOL TARTRATE)
25MG
Marketing Status: Prescription

Active Ingredient: METOPROLOL TARTRATE
Proprietary Name: METOPROLOL TARTRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076704
Product Number: 001
Approval Date: Jan 16, 2004
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

METOPROLOL TARTRATE (METOPROLOL TARTRATE)
37.5MG
Marketing Status: Prescription

Active Ingredient: METOPROLOL TARTRATE
Proprietary Name: METOPROLOL TARTRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 37.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076704
Product Number: 004
Approval Date: Mar 18, 2015
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

METOPROLOL TARTRATE (METOPROLOL TARTRATE)
50MG
Marketing Status: Prescription

Active Ingredient: METOPROLOL TARTRATE
Proprietary Name: METOPROLOL TARTRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076704
Product Number: 002
Approval Date: Jan 16, 2004
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

METOPROLOL TARTRATE (METOPROLOL TARTRATE)
75MG
Marketing Status: Prescription

Active Ingredient: METOPROLOL TARTRATE
Proprietary Name: METOPROLOL TARTRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076704
Product Number: 005
Approval Date: Mar 18, 2015
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

METOPROLOL TARTRATE (METOPROLOL TARTRATE)
100MG
Marketing Status: Prescription

Active Ingredient: METOPROLOL TARTRATE
Proprietary Name: METOPROLOL TARTRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A076704
Product Number: 003
Approval Date: Jan 16, 2004
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information