ANDA 213928, held by Pharmobedient. Aminocaproic Acid.
As of Nov 15, 2026, ANDA 213928 (Aminocaproic Acid), held by Pharmobedient, was first approved by FDA on Feb 12, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Aminocaproic acid 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 |
|---|---|---|---|
| Feb 12, 2021 | Original application | Approved | None posted |
| Aminocaproic Acid500MG · tablet;oral | Aminocaproic Acid | Rx |
| Aminocaproic Acid1GM · tablet;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
