ANDA 71192, held by Luitpold. Aminocaproic Acid.
As of Nov 15, 2026, ANDA 71192 (Aminocaproic Acid), held by Luitpold, was first approved by FDA on Dec 1, 1987, with 8 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Aminocaproic Acid Injection is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, 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 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 |
|---|---|---|---|
| Dec 1, 1987 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aminocaproic Acid250MG/ML · injectable;injection | Aminocaproic Acid | Rx |
| Feb 26, 2007 | Supplement 12Labeling | Approved | None posted |
| Feb 4, 2000 | Supplement 7Labeling | Approved | None posted |
| Oct 19, 1999 | Supplement 6Labeling | Approved | None posted |
| Aug 28, 1997 | Supplement 5Manufacturing | Approved | None posted |
| Feb 28, 1996 | Supplement 4Manufacturing | Approved | None posted |
| Jun 28, 1994 | Supplement 3Manufacturing | Approved | None posted |
| Dec 3, 1991 | Supplement 2Labeling | Approved | None posted |
| Aug 1, 1991 | Supplement 1Manufacturing | Approved | None posted |
| Dec 1, 1987 | 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
