Details for New Drug Application (NDA): 209988
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The generic ingredient in FUROSCIX is furosemide. There are twenty-two drug master file entries for this compound. Fifty-seven 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
Physiological Effect | Increased Diuresis at Loop of Henle |
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: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 80MG/10ML (8MG/ML) | ||||
Approval Date: | Oct 7, 2022 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Oct 7, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 3, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 3, 2034 | Product 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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