NDA 5521, held by Lilly. Heparin Sodium.
As of Nov 14, 2026, NDA 5521 (Heparin Sodium), held by Lilly, was first approved by FDA on May 19, 1944, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 19, 1944 | Original application | Approved | None posted |
| Heparin Sodium1,000 UNITS/ML · injectable;injection | Heparin Sodium | Discontinued |
| Heparin Sodium10,000 UNITS/ML · injectable;injection | Heparin Sodium | Discontinued |
| Heparin Sodium20,000 UNITS/ML · injectable;injection | Heparin Sodium | Discontinued |
| May 23, 2000 | Supplement 26Manufacturing | Approved | None posted |
| Apr 27, 1999 | Supplement 19Manufacturing | Approved | None posted |
| Jun 5, 1998 | Supplement 24Manufacturing | Approved | None posted |
| Jan 31, 1996 | Supplement 23Manufacturing | Approved | None posted |
| Nov 29, 1989 | Supplement 21Labeling | Approved | None posted |
| Oct 27, 1989 | Supplement 20Labeling | Approved | None posted |
| Jun 1, 1989 | Supplement 18Labeling | Approved | None posted |
| Jun 1, 1989 | Supplement 17Labeling | Approved | None posted |
| May 13, 1985 | Supplement 16Labeling | Approved | None posted |
| Jul 8, 1982 | Supplement 11Manufacturing | Approved | None posted |
| Jun 16, 1981 | Supplement 15Manufacturing | Approved | None posted |
| Mar 19, 1981 | Supplement 14Manufacturing | Approved | None posted |
| Jan 17, 1980 | Supplement 12Labeling | Approved | None posted |
| Sep 7, 1979 | Supplement 13Manufacturing | Approved | None posted |
| Mar 18, 1976 | Supplement 8Manufacturing | Approved | None posted |
| May 19, 1944 | 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
