Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 4,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/100ML | 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 |
---|---|---|---|---|---|---|---|
01/25/1989 | 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/pre96/019085Orig1s000rev.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/01/2019 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019805s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019805Orig1s042ltr.pdf | |
03/13/2014 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019805s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019805Orig1s036ltr.pdf | |
09/04/2019 | SUPPL-34 | 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-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/23/2011 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019805s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019805s029ltr.pdf | |
09/18/2002 | SUPPL-15 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
03/16/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
11/25/1997 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/27/1998 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
08/29/1996 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/24/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/05/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/30/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/25/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/18/1992 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
10/16/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/16/1990 | SUPPL-3 | 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 |
---|---|---|---|---|---|
09/04/2019 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018916s063,019339s052,019805s034lbl.pdf | |
08/01/2019 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019805s042lbl.pdf | |
03/13/2014 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019805s036lbl.pdf | |
12/23/2011 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019805s029lbl.pdf |