Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207620

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ENTRESTO (SACUBITRIL; VALSARTAN)
24MG;26MG
Marketing Status: Prescription

Active Ingredient: SACUBITRIL; VALSARTAN
Proprietary Name: ENTRESTO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 24MG;26MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N207620
Product Number: 001
Approval Date: Jul 7, 2015
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

ENTRESTO (SACUBITRIL; VALSARTAN)
49MG;51MG
Marketing Status: Prescription

Active Ingredient: SACUBITRIL; VALSARTAN
Proprietary Name: ENTRESTO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 49MG;51MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N207620
Product Number: 002
Approval Date: Jul 7, 2015
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

ENTRESTO (SACUBITRIL; VALSARTAN)
97MG;103MG
Marketing Status: Prescription

Active Ingredient: SACUBITRIL; VALSARTAN
Proprietary Name: ENTRESTO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 97MG;103MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N207620
Product Number: 003
Approval Date: Jul 7, 2015
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information