For restricted pulmonary blood flow. ANDA 75196, held by Meitheal. Alprostadil.
As of Nov 14, 2026, ANDA 75196 (Alprostadil), held by Meitheal, was first approved by FDA on Apr 30, 1999, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Alprostadil injection, USP is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 1999 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Alprostadil0.5MG/ML · injectable;injection | Alprostadil | Rx |
| Jun 19, 2020 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jun 19, 2020 | Supplement 21Labeling · Standard review | Approved | None posted |
| Apr 30, 1999 | 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
