Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204382

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VALSARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; VALSARTAN)
12.5MG;80MG
Marketing Status: Prescription

Active Ingredient: HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: VALSARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204382
Product Number: 001
Approval Date: Aug 11, 2023
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

VALSARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; VALSARTAN)
12.5MG;160MG
Marketing Status: Prescription

Active Ingredient: HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: VALSARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;160MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204382
Product Number: 002
Approval Date: Aug 11, 2023
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

VALSARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; VALSARTAN)
12.5MG;320MG
Marketing Status: Prescription

Active Ingredient: HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: VALSARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;320MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204382
Product Number: 004
Approval Date: Aug 11, 2023
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

VALSARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; VALSARTAN)
25MG;160MG
Marketing Status: Prescription

Active Ingredient: HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: VALSARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;160MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204382
Product Number: 003
Approval Date: Aug 11, 2023
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

VALSARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; VALSARTAN)
25MG;320MG
Marketing Status: Prescription

Active Ingredient: HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: VALSARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;320MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204382
Product Number: 005
Approval Date: Aug 11, 2023
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:  Prescription
Patent and Exclusivity Information