Drugs@FDA: FDA-Approved Drugs
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/20/1992 | 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 |
---|---|---|---|---|---|
12/15/2023 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019953s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019953Orig1s044ltr.pdf | |
05/12/2016 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019953s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019953Orig1s032ltr.pdf | |
08/30/2013 | SUPPL-30 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019953Orig1s030ltr.pdf | |
01/10/2013 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019953Orig1s029ltr.pdf | |
12/27/2011 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019953s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019953s025ltr.pdf | |
02/26/2009 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019953s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019953s021ltr.pdf | |
08/22/2014 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/13/2004 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/019953slr012ltr.pdf |
07/12/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/15/2002 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/22/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/01/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/05/1998 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/30/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/09/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/22/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
12/02/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/29/1993 | 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 |
---|---|---|---|---|---|
12/15/2023 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019953s044lbl.pdf | |
05/12/2016 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019953s032lbl.pdf | |
08/30/2013 | SUPPL-30 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s030lbl.pdf | |
08/30/2013 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s030lbl.pdf | |
01/10/2013 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s029lbl.pdf | |
12/27/2011 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019953s025lbl.pdf | |
02/26/2009 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019953s021lbl.pdf |
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 200 UNITS/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018609 | BAXTER HLTHCARE |
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019953 | B BRAUN |
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212441 | FRESENIUS KABI USA |
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018916 | HOSPIRA |
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018609 | BAXTER HLTHCARE |
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212441 | FRESENIUS KABI USA |
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018916 | HOSPIRA |
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.