Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090654

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METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE)
25MG;50MG
Marketing Status: Prescription

Active Ingredient: HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Proprietary Name: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090654
Product Number: 001
Approval Date: Jan 19, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE)
25MG;100MG
Marketing Status: Prescription

Active Ingredient: HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Proprietary Name: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090654
Product Number: 002
Approval Date: Jan 19, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE)
50MG;100MG
Marketing Status: Prescription

Active Ingredient: HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Proprietary Name: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG;100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090654
Product Number: 003
Approval Date: Jan 19, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information