Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020186

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ZIAC (BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE)
2.5MG;6.25MG
Marketing Status: Prescription

Active Ingredient: BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Proprietary Name: ZIAC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;6.25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020186
Product Number: 003
Approval Date: Mar 26, 1993
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZIAC (BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE)
5MG;6.25MG
Marketing Status: Prescription

Active Ingredient: BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Proprietary Name: ZIAC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;6.25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020186
Product Number: 001
Approval Date: Mar 26, 1993
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZIAC (BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE)
10MG;6.25MG
Marketing Status: Prescription

Active Ingredient: BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Proprietary Name: ZIAC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;6.25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020186
Product Number: 002
Approval Date: Mar 26, 1993
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Prescription
Patent and Exclusivity Information