Treats venous thrombosis and pulmonary embolism. NDA 17037, held by Hikma. Heparin Sodium.
As of Nov 14, 2026, NDA 17037 (Heparin Sodium), held by Hikma, was first approved by FDA on Mar 22, 1972, with 118 approved supplements and 0 published complete response letters.
Heparin Sodium Injection is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism; Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; Atrial fibrillation with embolization; Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); Prevention of clotting in arterial and cardiac surgery; Prophylaxis and treatment of peripheral arterial embolism. Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 1972 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Heparin Sodium1,000 UNITS/ML · injectable;injection | Heparin Sodium | RxReference drug |
| Heparin Sodium5,000 UNITS/ML · injectable;injection | Heparin Sodium | RxReference drug |
| Heparin Sodium10,000 UNITS/ML · injectable;injection | Heparin Sodium | RxReference drug |
| Heparin Sodium5,000 UNITS/0.5ML · injectable;injection | Heparin Sodium | Discontinued |
| Oct 24, 2024 | Supplement 201Labeling · Standard review | Approved | |
| Jan 14, 2020 | Supplement 187Manufacturing · Standard review | Approved | |
| May 18, 2019 | Supplement 183Manufacturing | Approved | |
| May 9, 2017 | Supplement 178Labeling · Standard review | Approved | |
| Dec 23, 2015 | Supplement 175Manufacturing · Standard review | Approved | None posted |
| Dec 2, 2015 | Supplement 174Manufacturing · Standard review | Approved | None posted |
| Oct 30, 2015 | Supplement 176Manufacturing · Standard review | Approved | None posted |
| Jan 5, 2015 | Supplement 173Manufacturing · Standard review | Approved | None posted |
| Jan 15, 2014 | Supplement 172Manufacturing · Standard review | Approved | None posted |
| Jan 9, 2014 | Supplement 171Manufacturing · Standard review | Approved | None posted |
| Aug 27, 2013 | Supplement 170Manufacturing · Standard review | Approved | None posted |
| Dec 23, 2011 | Supplement 169Labeling · Standard review | Approved | |
| Feb 23, 2011 | Supplement 168Labeling · Standard review | Approved | |
| Oct 1, 2009 | Supplement 165Labeling · Standard review | Approved | |
| Feb 17, 2009 | Supplement 162Labeling · Standard review | Approved | |
| Dec 14, 2007 | Supplement 161Labeling · Standard review | Approved | |
| Oct 4, 2006 | Supplement 158Labeling · Standard review | Approved | |
| Sep 2, 2005 | Supplement 154Manufacturing · Standard review | Approved | |
| Sep 2, 2005 | Supplement 155Manufacturing · Standard review | Approved | |
| Sep 2, 2005 | Supplement 156Manufacturing · Standard review | Approved | |
| Nov 25, 2002 | Supplement 150Manufacturing · Standard review | Approved | None posted |
| Nov 22, 2002 | Supplement 148Manufacturing · Standard review | Approved | None posted |
| Nov 22, 2002 | Supplement 151Manufacturing · Standard review | Approved | None posted |
| Nov 21, 2002 | Supplement 149Manufacturing · Standard review | Approved | None posted |
| Jul 15, 2002 | Supplement 147Manufacturing · Standard review | Approved | None posted |
| Feb 5, 2002 | Supplement 146Labeling · Standard review | Approved | None posted |
| Aug 31, 2001 | Supplement 145Manufacturing · Standard review | Approved | None posted |
| Nov 16, 2000 | Supplement 144Manufacturing · Standard review | Approved | None posted |
| May 31, 2000 | Supplement 143Manufacturing · Standard review | Approved | None posted |
| May 26, 2000 | Supplement 141Manufacturing · Standard review | Approved | None posted |
| May 26, 2000 | Supplement 142Manufacturing · Standard review | Approved | None posted |
| May 1, 2000 | Supplement 140Manufacturing · Standard review | Approved | None posted |
| Feb 15, 2000 | Supplement 139Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1999 | Supplement 136Labeling · Standard review | Approved | None posted |
| May 13, 1999 | Supplement 138Manufacturing · Standard review | Approved | None posted |
| Jun 23, 1998 | Supplement 133Labeling · Standard review | Approved | None posted |
| Feb 20, 1998 | Supplement 134Manufacturing · Standard review | Approved | None posted |
| Apr 24, 1997 | Supplement 132Manufacturing · Standard review | Approved | None posted |
| Mar 5, 1996 | Supplement 131Manufacturing · Standard review | Approved | None posted |
| Feb 9, 1993 | Supplement 130Manufacturing · Standard review | Approved | None posted |
| Apr 23, 1991 | Supplement 128Labeling | Approved | None posted |
| Sep 27, 1989 | Supplement 127Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1989 | Supplement 124Labeling | Approved | None posted |
| Jun 20, 1989 | Supplement 126Labeling | Approved | None posted |
| Jun 20, 1989 | Supplement 125Labeling | Approved | None posted |
| Oct 14, 1987 | Supplement 123Labeling | Approved | None posted |
| Sep 16, 1987 | Supplement 122Labeling | Approved | None posted |
| Jul 2, 1987 | Supplement 121Labeling | Approved | None posted |
| Jul 2, 1987 | Supplement 120Labeling | Approved | None posted |
| Apr 29, 1987 | Supplement 117Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1987 | Supplement 115Labeling | Approved | None posted |
| Apr 24, 1987 | Supplement 119Manufacturing · Standard review | Approved | None posted |
| Mar 10, 1987 | Supplement 118Manufacturing · Standard review | Approved | None posted |
| Sep 23, 1986 | Supplement 116Manufacturing · Standard review | Approved | None posted |
| Apr 7, 1986 | Supplement 112Manufacturing · Standard review | Approved | None posted |
| Jan 30, 1986 | Supplement 114Labeling | Approved | None posted |
| Jan 21, 1986 | Supplement 108Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1985 | Supplement 113Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1985 | Supplement 111Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1985 | Supplement 110Manufacturing · Standard review | Approved | None posted |
| May 13, 1985 | Supplement 109Labeling | Approved | None posted |
| Oct 11, 1984 | Supplement 105Labeling | Approved | None posted |
| Oct 11, 1984 | Supplement 107Labeling | Approved | None posted |
| Aug 2, 1984 | Supplement 104Manufacturing · Standard review | Approved | None posted |
| Mar 5, 1984 | Supplement 13Labeling | Approved | None posted |
| Dec 21, 1983 | Supplement 102Labeling | Approved | None posted |
| Sep 13, 1983 | Supplement 99Manufacturing · Standard review | Approved | None posted |
| Sep 5, 1983 | Supplement 101Labeling | Approved | None posted |
| Jun 10, 1983 | Supplement 100Manufacturing · Standard review | Approved | None posted |
| Oct 6, 1982 | Supplement 98Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1982 | Supplement 97Manufacturing · Standard review | Approved | None posted |
| Jun 4, 1982 | Supplement 96Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1981 | Supplement 95Labeling | Approved | None posted |
| May 22, 1981 | Supplement 94Labeling | Approved | None posted |
| Jan 21, 1980 | Supplement 93Manufacturing · Standard review | Approved | None posted |
| Sep 25, 1979 | Supplement 92Manufacturing · Standard review | Approved | None posted |
| Mar 6, 1979 | Supplement 91Manufacturing · Standard review | Approved | None posted |
| Jan 16, 1979 | Supplement 88Labeling | Approved | None posted |
| Jan 16, 1979 | Supplement 89Manufacturing · Standard review | Approved | None posted |
| Jan 16, 1979 | Supplement 90Manufacturing · Standard review | Approved | None posted |
| Oct 4, 1978 | Supplement 87Labeling | Approved | None posted |
| Aug 4, 1978 | Supplement 84Manufacturing · Standard review | Approved | None posted |
| Aug 4, 1978 | Supplement 86Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1978 | Supplement 82Labeling | Approved | None posted |
| Jul 31, 1978 | Supplement 83Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1978 | Supplement 85Labeling | Approved | None posted |
| Apr 27, 1978 | Supplement 77Labeling | Approved | None posted |
| Apr 27, 1978 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Jan 3, 1978 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| Dec 14, 1977 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Dec 14, 1977 | Supplement 75Labeling | Approved | None posted |
| Dec 14, 1977 | Supplement 79Labeling | Approved | None posted |
| Dec 14, 1977 | Supplement 80Manufacturing · Standard review | Approved | None posted |
| Dec 14, 1977 | Supplement 81Labeling | Approved | None posted |
| Aug 2, 1977 | Supplement 72Labeling | Approved | None posted |
| May 26, 1977 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| May 26, 1977 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Apr 26, 1977 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1977 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Oct 19, 1976 | Supplement 65Labeling | Approved | None posted |
| Oct 19, 1976 | Supplement 66Labeling | Approved | None posted |
| Sep 8, 1976 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Sep 8, 1976 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Sep 8, 1976 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Sep 8, 1976 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Sep 3, 1976 | Supplement 51Labeling | Approved | None posted |
| Sep 3, 1976 | Supplement 52Labeling | Approved | None posted |
| Jun 25, 1976 | Supplement 54Labeling | Approved | None posted |
| May 28, 1976 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Jan 9, 1976 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Sep 4, 1975 | Supplement 42Labeling | Approved | None posted |
| Sep 4, 1975 | Supplement 43Labeling | Approved | None posted |
| Sep 4, 1975 | Supplement 44Labeling | Approved | None posted |
| Sep 4, 1975 | Supplement 45Labeling | Approved | None posted |
| Sep 4, 1975 | Supplement 46Labeling | Approved | None posted |
| Sep 4, 1975 | Supplement 47Labeling | Approved | None posted |
| Apr 23, 1975 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Mar 24, 1975 | Supplement 38Labeling | Approved | None posted |
| Mar 22, 1972 | Original applicationNew formulation or manufacturer · Standard 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
