Product Details for NDA 209139
PREXXARTAN (VALSARTAN)
20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VALSARTAN
Proprietary Name: PREXXARTAN
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N209139
Product Number: 001
Approval Date: Dec 19, 2017
Applicant Holder Full Name: CARMEL BIOSCIENCES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PREXXARTAN (VALSARTAN)
Proprietary Name: PREXXARTAN
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N209139
Product Number: 001
Approval Date: Dec 19, 2017
Applicant Holder Full Name: CARMEL BIOSCIENCES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VALSARTAN
Proprietary Name: PREXXARTAN
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N209139
Product Number: 002
Approval Date: Dec 19, 2017
Applicant Holder Full Name: CARMEL BIOSCIENCES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PREXXARTAN
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N209139
Product Number: 002
Approval Date: Dec 19, 2017
Applicant Holder Full Name: CARMEL BIOSCIENCES INC
Marketing Status: Discontinued
Patent and Exclusivity Information