Product Details for NDA 217766
VASOPRESSIN IN SODIUM CHLORIDE 0.9% (VASOPRESSIN)
20UNITS/100ML (0.2UNITS/ML)
Marketing Status: Prescription
40UNITS/100ML (0.4UNITS/ML)
Marketing Status: Prescription
50UNITS/50ML (1UNIT/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
20UNITS/100ML (0.2UNITS/ML)
Marketing Status: Prescription
Active Ingredient: VASOPRESSIN
Proprietary Name: VASOPRESSIN IN SODIUM CHLORIDE 0.9%
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 20UNITS/100ML (0.2UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N217766
Product Number: 001
Approval Date: Jul 11, 2024
Applicant Holder Full Name: LONG GROVE PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
VASOPRESSIN IN SODIUM CHLORIDE 0.9% (VASOPRESSIN)
Proprietary Name: VASOPRESSIN IN SODIUM CHLORIDE 0.9%
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 20UNITS/100ML (0.2UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N217766
Product Number: 001
Approval Date: Jul 11, 2024
Applicant Holder Full Name: LONG GROVE PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
40UNITS/100ML (0.4UNITS/ML)
Marketing Status: Prescription
Active Ingredient: VASOPRESSIN
Proprietary Name: VASOPRESSIN IN SODIUM CHLORIDE 0.9%
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 40UNITS/100ML (0.4UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N217766
Product Number: 002
Approval Date: Jul 11, 2024
Applicant Holder Full Name: LONG GROVE PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
VASOPRESSIN IN SODIUM CHLORIDE 0.9% (VASOPRESSIN)
Proprietary Name: VASOPRESSIN IN SODIUM CHLORIDE 0.9%
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 40UNITS/100ML (0.4UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N217766
Product Number: 002
Approval Date: Jul 11, 2024
Applicant Holder Full Name: LONG GROVE PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
50UNITS/50ML (1UNIT/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VASOPRESSIN
Proprietary Name: VASOPRESSIN IN SODIUM CHLORIDE 0.9%
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50UNITS/50ML (1UNIT/ML) **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: N217766
Product Number: 003
Approval Date: Jul 11, 2024
Applicant Holder Full Name: LONG GROVE PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: VASOPRESSIN IN SODIUM CHLORIDE 0.9%
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50UNITS/50ML (1UNIT/ML) **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: N217766
Product Number: 003
Approval Date: Jul 11, 2024
Applicant Holder Full Name: LONG GROVE PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information