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-five suppliers are listed for this compound. Additional details are available on the furosemide profile page.
The generic ingredient in FUROSCIX is furosemide. There are twenty-two drug master file entries for this compound. Fifty-five 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: | 10,272,064 | Patent Expiration: | Apr 3, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,433,044 | 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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