Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
03/27/1985 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
---|---|---|---|---|---|
02/07/2024 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019339s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019339Orig1s068ltr.pdf | |
12/20/2018 | SUPPL-62 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019339s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019339Orig1s62Ltr.pdf | |
03/13/2014 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019339s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019339Orig1s054ltr.pdf | |
09/04/2019 | SUPPL-52 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018916s063,019339s052,019805s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018916Orig1s063, 019339Orig1s052, 019805Orig1s034ltr.pdf | |
02/08/2013 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/23/2011 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019339s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019339s047ltr.pdf | |
07/23/2009 | SUPPL-38 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019339s038ltr.pdf |
10/17/2008 | SUPPL-34 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019339s034ltr.pdf |
11/07/2002 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/19/1999 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
10/27/1998 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/27/1998 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/16/1998 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
06/09/1997 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/27/1998 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
02/07/1996 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/24/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/30/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/22/1995 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/10/1994 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/10/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/10/1994 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/10/1994 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
02/25/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/18/1992 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/16/1990 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/29/1986 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
08/03/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/24/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/01/1986 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/07/2024 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019339s068lbl.pdf | |
09/04/2019 | SUPPL-52 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018916s063,019339s052,019805s034lbl.pdf | |
12/20/2018 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019339s062lbl.pdf | |
12/20/2018 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019339s062lbl.pdf | |
03/13/2014 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019339s054lbl.pdf | |
12/23/2011 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019339s047lbl.pdf |
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 10,000 UNITS/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019339 | HOSPIRA |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019952 | B BRAUN |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019339 | HOSPIRA |
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 10,000 UNITS/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019339 | HOSPIRA |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019952 | B BRAUN |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019339 | HOSPIRA |
INJECTABLE;INJECTION; 5,000 UNITS/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019952 | B BRAUN |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019339 | HOSPIRA |