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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018303

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LOPRESSOR HCT (HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE)
25MG;50MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Proprietary Name: LOPRESSOR HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018303
Product Number: 001
Approval Date: Dec 31, 1984
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LOPRESSOR HCT (HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE)
25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Proprietary Name: LOPRESSOR HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018303
Product Number: 002
Approval Date: Dec 31, 1984
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LOPRESSOR HCT (HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE)
50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Proprietary Name: LOPRESSOR HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018303
Product Number: 003
Approval Date: Dec 31, 1984
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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