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Details for New Drug Application (NDA): 204958

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NDA 204958 describes KENGREAL, which is a drug marketed by Chiesi Usa Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the KENGREAL profile page.

The generic ingredient in KENGREAL is cangrelor. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cangrelor profile page.

Summary for NDA: 204958

Tradename:
KENGREAL
Applicant:
Chiesi Usa Inc
Ingredient:
cangrelor
Patents:5
Formulation / Manufacturing:see details

Pharmacology for NDA: 204958

Mechanism of ActionP2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation

Suppliers and Packaging for NDA: 204958

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KENGREAL
cangrelor
POWDER;IV (INFUSION) 204958 NDA The Medicines Company 65293-003 65293-003-10 10 VIAL, SINGLE-USE in 1 CARTON (65293-003-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (65293-003-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)Strength50MG/VIAL
Approval Date:Jun 22, 2015TE:RLD:Yes
Patent:9,295,687Patent Expiration:Jul 10, 2035Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Jun 22, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:6,114,313Patent Expiration:Dec 11, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:P2Y12 PLATELET INHIBITOR FOR USE AS ADJUNCT TO PERCUTANEOUS CORONARY INTERVENTIONTO REDUCE RISK OF VARIOUS DISEASES/CONDITIONS IN PATIENTS NOT TREATED WITH A P2Y12 PLATELET INHIBITOR AND NOT GIVEN A GLYCOPROTEIN IIB/IIIA INHIBITOR


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