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 |
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 |