Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077492

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VALSARTAN (VALSARTAN)
40MG
Marketing Status: Prescription

Active Ingredient: VALSARTAN
Proprietary Name: VALSARTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077492
Product Number: 001
Approval Date: Jun 26, 2014
Applicant Holder Full Name: OHM LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VALSARTAN (VALSARTAN)
80MG
Marketing Status: Prescription

Active Ingredient: VALSARTAN
Proprietary Name: VALSARTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077492
Product Number: 002
Approval Date: Jun 26, 2014
Applicant Holder Full Name: OHM LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VALSARTAN (VALSARTAN)
160MG
Marketing Status: Prescription

Active Ingredient: VALSARTAN
Proprietary Name: VALSARTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 160MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077492
Product Number: 003
Approval Date: Jun 26, 2014
Applicant Holder Full Name: OHM LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VALSARTAN (VALSARTAN)
320MG
Marketing Status: Prescription

Active Ingredient: VALSARTAN
Proprietary Name: VALSARTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 320MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077492
Product Number: 004
Approval Date: Jun 26, 2014
Applicant Holder Full Name: OHM LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information