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Generated: November 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021697

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NDA 021697 describes VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, which is a drug marketed by Cumberland Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER profile page.

The generic ingredient in VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER is conivaptan hydrochloride. One supplier is listed for this compound. Additional details are available on the conivaptan hydrochloride profile page.
Summary for 021697
Tradename:VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER
Applicant:Cumberland Pharms
Ingredient:conivaptan hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021697
Suppliers and Packaging for NDA: 021697
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VAPRISOL conivaptan hydrochloride INJECTABLE;INTRAVENOUS 021697 NDA Cumberland Pharmaceuticals Inc. 66220-160 66220-160-10 1 BAG in 1 BOX (66220-160-10) > 1 POUCH in 1 BAG > 100 mL in 1 POUCH
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER conivaptan hydrochloride INJECTABLE;INTRAVENOUS 021697 NDA Cumberland Pharmaceuticals Inc. 66220-160 66220-160-10 1 BAG in 1 BOX (66220-160-10) > 1 POUCH in 1 BAG > 100 mL in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrength20MG/4ML (5MG/ML)
Approval Date:Dec 29, 2005TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Dec 15, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF USING ANTAGONIST OF ARGININE VASOPRESSIN (AVA) V1A AND V2 RECEPTORS FOR INTRAVENOUS TREATMENT OF PATIENTS WITH EUVOLEMIC HYPONATREMIA
Patent:➤ Sign UpPatent Expiration:Dec 15, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF USING ANTAGONIST OF ARGININE VASOPRESSIN (AVA) V1A AND V2 RECEPTORS FOR INTRAVENOUS TREATMENT OF PATIENTS WITH HYPERVOLEMIC HYPONATREMIA

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength20MG/100ML (0.2MG/ML)
Approval Date:Oct 8, 2008TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 15, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF USING ANTAGONIST OF ARGININE VASOPRESSIN (AVA) V1A AND V2 RECEPTORS FOR INTRAVENOUS TREATMENT OF PATIENTS WITH EUVOLEMIC HYPONATREMIA

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