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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020287
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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/05/2020 SUPPL-76 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020287Orig1s076lbl.pdf
12/05/2020 SUPPL-76 Labeling-Package Insert 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
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