NDA 17007, held by Hikma. Heparin Sodium.
As of Nov 13, 2026, NDA 17007 (Heparin Sodium, Heparin Lock Flush), held by Hikma, was first approved by FDA on May 28, 1974, with 31 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 28, 1974 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Heparin Sodium1,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Heparin Sodium | DiscontinuedReference drug |
| Heparin Sodium5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Heparin Sodium | DiscontinuedReference drug |
| Heparin Sodium7,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Heparin Sodium | DiscontinuedReference drug |
| Heparin Sodium10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Heparin Sodium | DiscontinuedReference drug |
| Heparin Sodium15,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Heparin Sodium | DiscontinuedReference drug |
| Heparin Sodium20,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Heparin Sodium | DiscontinuedReference drug |
| Heparin Sodium2,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Heparin Sodium | DiscontinuedReference drug |
| Heparin Lock Flush10 UNITS/ML · injectable; injection | Heparin Sodium | Discontinued |
| Heparin Lock Flush100 UNITS/ML · injectable; injection | Heparin Sodium | Discontinued |
| Heparin Sodium5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Heparin Sodium | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 24, 2024 | Supplement 40Labeling · Standard review | Approved | |
| Mar 27, 2018 | Supplement 39Labeling · Standard review | Approved | |
| Sep 6, 2000 | Supplement 38Labeling · Standard review | Approved | |
| Mar 5, 1997 | Supplement 36Labeling · Standard review | Approved | None posted |
| May 20, 1996 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Oct 20, 1993 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Jun 14, 1993 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Feb 28, 1991 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Jul 20, 1990 | Supplement 31Labeling | Approved | None posted |
| Jul 13, 1989 | Supplement 29Labeling | Approved | None posted |
| Jun 29, 1989 | Supplement 28Labeling | Approved | None posted |
| Jul 29, 1987 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Apr 14, 1987 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Mar 5, 1987 | Supplement 22Labeling | Approved | None posted |
| Apr 7, 1986 | Supplement 15Labeling | Approved | None posted |
| Oct 19, 1983 | Supplement 19Labeling | Approved | None posted |
| Aug 29, 1983 | Supplement 18Labeling | Approved | None posted |
| May 25, 1983 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Jul 30, 1982 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| May 14, 1981 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Jul 2, 1980 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Jul 2, 1980 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Oct 4, 1978 | Supplement 11Labeling | Approved | None posted |
| Jul 3, 1978 | Supplement 10Labeling | Approved | None posted |
| Jul 3, 1978 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Feb 2, 1978 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Feb 2, 1978 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Dec 29, 1976 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Dec 12, 1975 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Oct 17, 1975 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Mar 28, 1975 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| May 28, 1974 | Original applicationNew dosage form · Priority review | 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
