Treats edema associated with congestive heart failure, cirrhosis … the nephrotic syndrome. ANDA 212174, held by Eugia Pharma. Furosemide.
As of Nov 14, 2026, ANDA 212174 (Furosemide), held by Eugia Pharma, was first approved by FDA on May 3, 2019, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema: Furosemide Injection is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide Injection is particularly useful when an agent with greater diuretic potential is desired. Furosemide Injection is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of Furosemide Injection is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 3, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Furosemide10MG/ML · injectable;injection | Furosemide | Rx |
| May 8, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 3, 2019 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
