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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 209988


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NDA 209988 describes FUROSCIX, which is a drug marketed by Scpharmaceuticals and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the FUROSCIX profile page.

The generic ingredient in FUROSCIX is furosemide. There are twenty-two drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the furosemide profile page.
Summary for 209988
Tradename:FUROSCIX
Applicant:Scpharmaceuticals
Ingredient:furosemide
Patents:3
Pharmacology for NDA: 209988
Medical Subject Heading (MeSH) Categories for 209988
Suppliers and Packaging for NDA: 209988
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FUROSCIX furosemide SOLUTION;SUBCUTANEOUS 209988 NDA scPharmaceuticals Inc. 71767-100 71767-100-01 1 CARTON in 1 KIT (71767-100-01) / 1 CARTRIDGE in 1 CARTON / 10 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength80MG/10ML (8MG/ML)
Approval Date:Oct 7, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 7, 2025
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Apr 3, 2034Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Apr 3, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF A LIQUID FORMULATION COMPRISING FUROSEMIDE TO TREAT CONGESTION DUE TO FLUID OVERLOAD (EDEMA) IN ADULTS WITH NYHA CLASS II/III CHRONIC HEART FAILURE

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