U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 204485

Expand all

VASOSTRICT (VASOPRESSIN)
20UNITS/ML (20UNITS/ML)
Marketing Status: Prescription
Active Ingredient: VASOPRESSIN
Proprietary Name: VASOSTRICT
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 20UNITS/ML (20UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N204485
Product Number: 001
Approval Date: Apr 17, 2014
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
VASOSTRICT (VASOPRESSIN)
20UNITS/100ML (0.2UNITS/ML)
Marketing Status: Prescription
Active Ingredient: VASOPRESSIN
Proprietary Name: VASOSTRICT
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 20UNITS/100ML (0.2UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N204485
Product Number: 005
Approval Date: Apr 21, 2021
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
VASOSTRICT (VASOPRESSIN)
40UNITS/100ML (0.4UNITS/ML)
Marketing Status: Prescription
Active Ingredient: VASOPRESSIN
Proprietary Name: VASOSTRICT
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 40UNITS/100ML (0.4UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204485
Product Number: 003
Approval Date: Apr 15, 2020
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
VASOSTRICT (VASOPRESSIN)
200UNITS/10ML (20UNITS/ML)
Marketing Status: Prescription
Active Ingredient: VASOPRESSIN
Proprietary Name: VASOSTRICT
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 200UNITS/10ML (20UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204485
Product Number: 002
Approval Date: Dec 17, 2016
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
VASOSTRICT (VASOPRESSIN)
50UNITS/50ML (1UNITS/ML)
Marketing Status: Discontinued
Active Ingredient: VASOPRESSIN
Proprietary Name: VASOSTRICT
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50UNITS/50ML (1UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204485
Product Number: 006
Approval Date: Apr 12, 2023
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
VASOSTRICT (VASOPRESSIN)
60UNITS/100ML (0.6UNITS/ML)
Marketing Status: Discontinued
Active Ingredient: VASOPRESSIN
Proprietary Name: VASOSTRICT
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 60UNITS/100ML (0.6UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204485
Product Number: 004
Approval Date: Apr 15, 2020
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top