Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017651
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 02/10/1978 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017651_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/24/2024 | SUPPL-78 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017651s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017651Orig1s078ltr.pdf | |
| 06/07/2021 | SUPPL-69 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017029Orig1s159; 017651Orig1s069ltr.pdf |
| 07/02/2020 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017029s156,017651s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017029Orig1s156, 017651Orig1s066ltr.pdf | |
| 11/15/2016 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/2013 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/2014 | SUPPL-59 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017029Orig1s135,017651Orig1s059.pdf |
| 11/13/2015 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/2013 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/2013 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/2011 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017029s131017651s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s131,017651s055ltr.pdf | |
| 06/24/2011 | SUPPL-52 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s128,017651s052ltr.pdf |
| 06/11/2010 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017029s120,017651s048ltr.pdf | |
| 04/01/2009 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017651s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017651s046ltr.pdf | |
| 12/14/2007 | SUPPL-42 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017651s042ltr.pdf |
| 01/07/2003 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1999 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1997 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1992 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 07/31/1992 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 07/12/1995 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1996 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/25/1993 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 02/09/1989 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/19/1988 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 01/08/1985 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1985 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 09/19/1984 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1984 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/26/1984 | SUPPL-16 | Efficacy |
Label is not available on this site. |
||
| 12/19/1983 | SUPPL-15 | Efficacy |
Label is not available on this site. |
||
| 01/12/1983 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1982 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1981 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1980 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/18/1979 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/18/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/25/1980 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/29/1979 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/08/1979 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/1979 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/08/1979 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/13/1979 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/08/1979 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/15/1978 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/24/2024 | SUPPL-78 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017651s078lbl.pdf | |
| 07/02/2020 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017029s156,017651s066lbl.pdf | |
| 12/23/2011 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017029s131017651s055lbl.pdf | |
| 06/11/2010 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.pdf | |
| 04/01/2009 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017651s046lbl.pdf |
HEPARIN SODIUM
INJECTABLE;INJECTION; 5,000 UNITS/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211007 | EMERGE BIOSCIENCE |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212061 | EMERGE BIOSCIENCE |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017651 | FRESENIUS KABI USA |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206552 | FRESENIUS KABI USA |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205323 | GLAND |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017037 | HIKMA |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090571 | HOSPIRA INC |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203851 | PHARMOBEDIENT |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091682 | PLANO PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090808 | SAGENT PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202733 | SHENZHEN TECHDOW |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202957 | SHENZHEN TECHDOW |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |