Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018609
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 2,000 UNITS/1000ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 500 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 |
|---|---|---|---|---|---|---|---|
| 04/28/1982 | 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 |
|---|---|---|---|---|---|
| 01/03/2022 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018609s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018609Orig1s058ltr.pdf | |
| 07/15/2019 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018609s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018609Orig1s054ltr.pdf | |
| 07/25/2016 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/2015 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/2010 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018609s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018609s044ltr.pdf | |
| 02/27/2012 | SUPPL-42 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018609s042ltr.pdf |
| 08/14/2001 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/23/1999 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/21/2001 | SUPPL-35 | Labeling |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18609s33s35lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018609_s035_Heparin_Sodium.pdf | |
| 06/01/1999 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/2001 | SUPPL-33 | Labeling |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18609s33s35lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018609_s033_Haparin_Sodium.pdf | |
| 05/20/1997 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/17/1996 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 03/10/1994 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/1994 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1993 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1991 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1990 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1991 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/24/1989 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/29/1987 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/01/1986 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/01/1986 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/20/1985 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/20/1985 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/08/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/16/1984 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1984 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1984 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/08/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/06/1984 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1984 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/06/1984 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/09/1982 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/09/1982 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1982 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/03/2022 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018609s058lbl.pdf | |
| 07/15/2019 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018609s054lbl.pdf | |
| 08/13/2010 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018609s044lbl.pdf | |
| 08/21/2001 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18609s33s35lbl.pdf | |
| 08/21/2001 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18609s33s35lbl.pdf |
HEPARIN SODIUM 1,000 UNITS AND 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 AND 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 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.