Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021697

Expand all

VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER (CONIVAPTAN HYDROCHLORIDE)
20MG/100ML (0.2MG/ML)
Marketing Status: Prescription

Active Ingredient: CONIVAPTAN HYDROCHLORIDE
Proprietary Name: VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 20MG/100ML (0.2MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021697
Product Number: 002
Approval Date: Oct 8, 2008
Applicant Holder Full Name: CUMBERLAND PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VAPRISOL (CONIVAPTAN HYDROCHLORIDE)
20MG/4ML (5MG/ML)
Marketing Status: Discontinued

Active Ingredient: CONIVAPTAN HYDROCHLORIDE
Proprietary Name: VAPRISOL
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 20MG/4ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021697
Product Number: 001
Approval Date: Dec 29, 2005
Applicant Holder Full Name: CUMBERLAND PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information