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Last Updated: November 22, 2024

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 two suppliers. 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. Four suppliers are listed for this compound. Additional details are available on the sincalide profile page.
Summary for 017697
Tradename:KINEVAC
Applicant:Bracco
Ingredient:sincalide
Patents:0
Pharmacology for NDA: 017697
Suppliers and Packaging for NDA: 017697
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KINEVAC sincalide POWDER;INTRAVENOUS 017697 NDA Bracco Diagnostics Inc. 0270-0556 0270-0556-15 10 VIAL in 1 PACKAGE (0270-0556-15) / 5 mL in 1 VIAL
KINEVAC sincalide POWDER;INTRAVENOUS 017697 NDA Fresenius Kabi USA, LLC 63323-579 63323-579-05 10 VIAL in 1 PACKAGE (63323-579-05) / 5 mL in 1 VIAL (63323-579-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength0.005MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Expired US Patents for NDA 017697

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bracco KINEVAC sincalide POWDER;INTRAVENOUS 017697-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Bracco KINEVAC sincalide POWDER;INTRAVENOUS 017697-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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