Treats edema associated with congestive heart failure, cirrhosis … the nephrotic syndrome. ANDA 213902, held by Gland. Furosemide.
As of Nov 13, 2026, ANDA 213902 (Furosemide), held by Gland, was first approved by FDA on Jul 1, 2020, with 0 approved supplements 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 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 is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Furosemide10MG/ML · injectable;injection | Furosemide | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
