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Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017697

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NDA 017697 describes KINEVAC, which is a drug marketed by Bracco 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 KINEVAC profile page.

The generic ingredient in KINEVAC is sincalide. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sincalide profile page.
Summary for 017697
Tradename:KINEVAC
Applicant:Bracco
Ingredient:sincalide
Patents:1
Generic Entry Opportunity Date for 017697
Generic Entry Date for 017697*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INJECTION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 017697
Ingredient-typeCholecystokinin
Suppliers and Packaging for NDA: 017697
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KINEVAC sincalide INJECTABLE;INJECTION 017697 NDA Bracco Diagnostics Inc. 0270-0556 0270-0556-15 10 VIAL in 1 PACKAGE (0270-0556-15) > 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.005MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 16, 2022Product Flag?YSubstance Flag?Delist Request?

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