ANDA 212780, held by Amneal. Aminocaproic Acid.
As of Nov 15, 2026, ANDA 212780 (Aminocaproic Acid), held by Amneal, was first approved by FDA on Aug 23, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Aminocaproic acid oral solution is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 23, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aminocaproic Acid0.25GM/ML · solution;oral | Aminocaproic Acid | Rx |
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
