Drugs@FDA: FDA-Approved Drugs
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 | 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 | MYLAN LABS LTD |
HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211007 | NANJING KING-FRIEND |
HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212061 | NANJING KING-FRIEND |
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 | 091682 | SANDOZ |
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 |