Product Details for ANDA 215666
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE)
2.5MG;6.25MG
Marketing Status: Prescription
5MG;6.25MG
Marketing Status: Prescription
10MG;6.25MG
Marketing Status: Prescription
2.5MG;6.25MG
Marketing Status: Prescription
Active Ingredient: BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Proprietary Name: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;6.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A215666
Product Number: 001
Approval Date: Nov 4, 2022
Applicant Holder Full Name: CADILA HEALTHCARE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE)
Proprietary Name: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;6.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A215666
Product Number: 001
Approval Date: Nov 4, 2022
Applicant Holder Full Name: CADILA HEALTHCARE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
5MG;6.25MG
Marketing Status: Prescription
Active Ingredient: BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Proprietary Name: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;6.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A215666
Product Number: 002
Approval Date: Nov 4, 2022
Applicant Holder Full Name: CADILA HEALTHCARE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE)
Proprietary Name: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;6.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A215666
Product Number: 002
Approval Date: Nov 4, 2022
Applicant Holder Full Name: CADILA HEALTHCARE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
10MG;6.25MG
Marketing Status: Prescription
Active Ingredient: BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Proprietary Name: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;6.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A215666
Product Number: 003
Approval Date: Nov 4, 2022
Applicant Holder Full Name: CADILA HEALTHCARE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;6.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A215666
Product Number: 003
Approval Date: Nov 4, 2022
Applicant Holder Full Name: CADILA HEALTHCARE LTD
Marketing Status: Prescription
Patent and Exclusivity Information