Prevents ischemic complications of unstable angina and non-Q-wave myocardial infarction. NDA 20287, held by Pfizer. Dalteparin Sodium.
As of Nov 13, 2026, NDA 20287 (Fragmin), held by Pfizer, was first approved by FDA on Dec 22, 1994, with 46 approved supplements and 0 published complete response letters.
FRAGMIN is a low molecular weight heparin (LMWH) indicated for
| Oct 15, 2024 | Supplement 80Efficacy (new indication or use) · Standard review | Approved | |
| May 16, 2019 | Supplement 72Efficacy (new indication or use) · Priority review | Approved | |
| May 1, 2007 | Supplement 35Efficacy (new indication or use) | Approved | |
| Dec 10, 2003 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| May 25, 1999 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Mar 30, 1999 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Mar 18, 1996 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | None posted |
| Dec 22, 1994 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Fragmin2,500IU/0.2ML (12,500IU/ML) · injectable;subcutaneous | Dalteparin Sodium | RxReference drug |
| Fragmin10,000IU/0.4ML (25,000IU/ML) · injectable;subcutaneous | Dalteparin Sodium | Discontinued |
| Fragmin5,000IU/0.2ML (25,000IU/ML) · injectable;subcutaneous | Dalteparin Sodium | RxReference drug |
| Fragmin10,000IU/ML (10,000IU/ML) · injectable;subcutaneous | Dalteparin Sodium | RxReference drug |
| Fragmin7,500IU/0.3ML (25,000IU/ML) · injectable;subcutaneous | Dalteparin Sodium | RxReference drug |
| Fragmin95,000IU/3.8ML (25,000IU/ML) · injectable;subcutaneous | Dalteparin Sodium | RxReference drug |
| Fragmin95,000IU/9.5ML (10,000IU/ML) · injectable;subcutaneous | Dalteparin Sodium | Discontinued |
| Fragmin7,500 IU/0.75ML · injectable;injection | Dalteparin Sodium | Discontinued |
| Fragmin12,500IU/0.5ML (25,000IU/ML) · injectable;subcutaneous | Dalteparin Sodium | RxReference drug |
| Fragmin15,000IU/0.6ML (25,000IU/ML) · injectable;subcutaneous | Dalteparin Sodium | RxReference drug |
| Fragmin18,000IU/0.72ML (25,000IU/ML) · injectable;subcutaneous | Dalteparin Sodium | RxReference drug |
| Fragmin10,000IU/4ML (2,500IU/ML) · injectable;subcutaneous | Dalteparin Sodium | RxReference drug |
| Oct 24, 2024 | Supplement 81Labeling · Standard review | Approved | |
| Oct 15, 2024 | Supplement 80Efficacy (new indication or use) · Standard review | Approved | |
| Dec 5, 2020 | Supplement 76Labeling · Standard review | Approved | |
| Jun 26, 2020 | Supplement 75Labeling · Standard review | Approved | |
| Jun 26, 2020 | Supplement 74Labeling · Standard review | Approved | |
| Sep 25, 2019 | Supplement 60Labeling · Standard review | Approved | None posted |
| May 16, 2019 | Supplement 72Efficacy (new indication or use) · Priority review | Approved | |
| May 12, 2017 | Supplement 69Labeling · Standard review | Approved | |
| Jan 26, 2017 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Aug 4, 2016 | Supplement 67Labeling · Standard review | Approved | |
| Sep 29, 2015 | Supplement 63Labeling · Standard review | Approved | |
| Jan 27, 2015 | Supplement 62Labeling · Standard review | Approved | |
| Oct 22, 2013 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Sep 27, 2013 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Oct 22, 2010 | Supplement 50Labeling · Standard review | Approved | |
| Dec 23, 2009 | Supplement 49Labeling · Standard review | Approved | |
| May 1, 2007 | Supplement 35Efficacy (new indication or use) | Approved | |
| Apr 21, 2004 | Supplement 34Labeling · Standard review | Approved | |
| Dec 10, 2003 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Jun 30, 2003 | Supplement 31Labeling · Standard review | Approved | |
| Feb 27, 2003 | Supplement 11Labeling · Standard review | Approved | |
| Nov 19, 2002 | Supplement 29Labeling · Standard review | Approved | |
| Nov 1, 2002 | Supplement 27Labeling · Standard review | Approved | |
| Sep 11, 2002 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Apr 26, 2002 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Apr 4, 2002 | Supplement 23Manufacturing · Standard review | Approved | |
| Apr 4, 2002 | Supplement 22Manufacturing · Standard review | Approved | |
| Apr 4, 2002 | Supplement 21Manufacturing · Standard review | Approved | |
| Mar 13, 2002 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Sep 4, 2001 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jun 19, 2001 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Nov 14, 2000 | Supplement 17Manufacturing · Standard review | Approved | |
| Aug 3, 2000 | Supplement 18Labeling · Standard review | Approved | |
| Aug 5, 1999 | Supplement 15Manufacturing · Standard review | Approved | |
| Jun 30, 1999 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| May 25, 1999 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Mar 30, 1999 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jan 22, 1999 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jan 30, 1998 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jan 30, 1998 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1997 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jan 23, 1997 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Sep 24, 1996 | Supplement 5Labeling · Standard review | Approved | |
| Mar 18, 1996 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | None posted |
| Mar 18, 1996 | Supplement 2Manufacturing · Standard review | Approved | |
| Aug 14, 1995 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 22, 1994 | Original applicationNew molecular entity · 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
