Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020287
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FRAGMIN | DALTEPARIN SODIUM | 2,500IU/0.2ML (12,500IU/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | Yes | No |
| FRAGMIN | DALTEPARIN SODIUM | 10,000IU/0.4ML (25,000IU/ML) | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
| FRAGMIN | DALTEPARIN SODIUM | 5,000IU/0.2ML (25,000IU/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | Yes | No |
| FRAGMIN | DALTEPARIN SODIUM | 10,000IU/ML (10,000IU/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | Yes | No |
| FRAGMIN | DALTEPARIN SODIUM | 7,500IU/0.3ML (25,000IU/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | Yes | No |
| FRAGMIN | DALTEPARIN SODIUM | 95,000IU/3.8ML (25,000IU/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | Yes | Yes |
| FRAGMIN | DALTEPARIN SODIUM | 95,000IU/9.5ML (10,000IU/ML) | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
| FRAGMIN | DALTEPARIN SODIUM | 7,500 IU/0.75ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| FRAGMIN | DALTEPARIN SODIUM | 12,500IU/0.5ML (25,000IU/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | Yes | No |
| FRAGMIN | DALTEPARIN SODIUM | 15,000IU/0.6ML (25,000IU/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | Yes | No |
| FRAGMIN | DALTEPARIN SODIUM | 18,000IU/0.72ML (25,000IU/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | Yes | No |
| FRAGMIN | DALTEPARIN SODIUM | 10,000IU/4ML (2,500IU/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/22/1994 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/05/2020 | SUPPL-76 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020287Orig1s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020287Orig1s076ltr.pdf | |
| 06/26/2020 | SUPPL-75 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020287s074s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020287Orig1s074, 075ltr.pdf | |
| 06/26/2020 | SUPPL-74 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020287s074s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020287Orig1s074, 075ltr.pdf | |
| 05/16/2019 | SUPPL-72 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020287s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020287Orig1s072ltr.pdf | |
| 05/12/2017 | SUPPL-69 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020287s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020287Orig1s069ltr.pdf | |
| 01/26/2017 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/2016 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020287s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020287Orig1s067ltr.pdf | |
| 09/29/2015 | SUPPL-63 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020287s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020287Orig1s063ltr.pdf | |
| 01/27/2015 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020287s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020287Orig1s062ltr.pdf | |
| 10/22/2013 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/2019 | SUPPL-60 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/27/2013 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/2010 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020287s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020287s050ltr.pdf | |
| 12/23/2009 | SUPPL-49 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020287s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020287s049ltr.pdf | |
| 05/01/2007 | SUPPL-35 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020287s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020287s035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020287Orig1s035.pdf | |
| 04/21/2004 | SUPPL-34 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20287slr034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020287_s034_FRAGMIN INJECTION.pdf |
| 12/10/2003 | SUPPL-32 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20287se1-032_fragmin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20287se1-032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020287_s032_FRAGMIN INJECTION.pdf | |
| 06/30/2003 | SUPPL-31 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20287slr031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020287_s031_FRAGMIN INJECTION.pdf |
| 11/19/2002 | SUPPL-29 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287slr029ltr.pdf |
| 09/11/2002 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/2002 | SUPPL-27 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287slr027LTR.pdf |
| 04/26/2002 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/19/2001 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/2002 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/2002 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287s21ltr.pdf |
| 04/04/2002 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287s21ltr.pdf |
| 04/04/2002 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287s21ltr.pdf |
| 09/04/2001 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/2000 | SUPPL-18 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20287S18LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20287S18LTR.PDF | |
| 11/14/2000 | SUPPL-17 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020287_S017_FRAGMIN_AP.pdf |
| 06/30/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/1999 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287_S015_FRAGMIN_AP.pdf |
| 01/22/1999 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/27/2003 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20287slr011ltr.pdf |
| 05/25/1999 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287S10_Fragmin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287S10_Fragmin_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287S10_Fragmin.cfm | |
| 01/30/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/30/1999 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20287s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20287s8ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287S008_Fragmin.cfm | |
| 01/23/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1998 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/24/1996 | SUPPL-5 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020287a_s005edt.pdf |
| 04/08/1997 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1996 | SUPPL-3 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 03/18/1996 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020287_s002_FRAGMIN INJECTION.pdf |
| 08/14/1995 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/05/2020 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020287Orig1s076lbl.pdf | |
| 12/05/2020 | SUPPL-76 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020287Orig1s076lbl.pdf | |
| 06/26/2020 | SUPPL-75 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020287s074s075lbl.pdf | |
| 06/26/2020 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020287s074s075lbl.pdf | |
| 05/16/2019 | SUPPL-72 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020287s072lbl.pdf | |
| 05/12/2017 | SUPPL-69 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020287s069lbl.pdf | |
| 08/04/2016 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020287s067lbl.pdf | |
| 09/29/2015 | SUPPL-63 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020287s063lbl.pdf | |
| 01/27/2015 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020287s062lbl.pdf | |
| 10/22/2010 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020287s050lbl.pdf | |
| 12/23/2009 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020287s049lbl.pdf | |
| 05/01/2007 | SUPPL-35 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020287s035lbl.pdf | |
| 12/10/2003 | SUPPL-32 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20287se1-032_fragmin_lbl.pdf | |
| 08/03/2000 | SUPPL-18 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20287S18LBL.PDF | |
| 05/25/1999 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287S10_Fragmin_prntlbl.pdf | |
| 03/30/1999 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20287s8lbl.pdf |