Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020287
Company: PFIZER INC
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
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
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.

10/15/2013 SUPPL-60 Labeling

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
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

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