Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017029
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% | HEPARIN SODIUM | 40 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% | HEPARIN SODIUM | 50 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% | HEPARIN SODIUM | 100 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% | HEPARIN SODIUM | 50 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% | HEPARIN SODIUM | 100 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 02/22/1972 | 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 |
|---|---|---|---|---|---|
| 06/07/2021 | SUPPL-159 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017029s159lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017029Orig1s159; 017651Orig1s069ltr.pdf | |
| 07/02/2020 | SUPPL-156 | 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 | |
| 11/16/2018 | SUPPL-141 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017029s141lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017029Orig1s141ltr.pdf | |
| 08/24/2017 | SUPPL-140 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017029s140lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017029Orig1s140ltr.pdf | |
| 06/09/2016 | SUPPL-139 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/2015 | SUPPL-137 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/2013 | SUPPL-136 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/2014 | SUPPL-135 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017029Orig1s135,017651Orig1s059.pdf |
| 03/09/2015 | SUPPL-134 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/2011 | SUPPL-131 | 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 | |
| 12/23/2015 | SUPPL-129 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/2011 | SUPPL-128 | 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-120 | 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 | |
| 03/31/2011 | SUPPL-115 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/23/2008 | SUPPL-108 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017029s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017029s108ltr.pdf | |
| 03/22/2002 | SUPPL-99 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17029s099ltr.pdf |
| 12/13/1999 | SUPPL-98 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/2000 | SUPPL-97 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/04/1997 | SUPPL-96 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/24/1997 | SUPPL-95 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1998 | SUPPL-94 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1995 | SUPPL-84 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1994 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1996 | SUPPL-73 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/25/1993 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 08/06/1998 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1998 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1989 | SUPPL-61 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/22/1988 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 02/16/1988 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/01/1989 | SUPPL-57 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/26/1992 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 04/28/1986 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1986 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 09/22/1987 | SUPPL-51 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/22/1987 | SUPPL-50 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/29/1985 | SUPPL-49 | Efficacy |
Label is not available on this site. |
||
| 11/06/1984 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/05/1985 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/05/1985 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/05/1985 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/05/1985 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/05/1985 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/05/1985 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/02/1983 | SUPPL-41 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/02/1983 | SUPPL-40 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/02/1983 | SUPPL-39 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/02/1983 | SUPPL-38 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/16/1985 | SUPPL-37 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/02/1983 | SUPPL-36 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/02/1983 | SUPPL-34 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/04/1983 | SUPPL-33 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/21/1982 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/1982 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/1982 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 09/17/1982 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/24/1981 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 03/24/1981 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/1979 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/1979 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1978 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/21/1978 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/1978 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/14/1977 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/03/1976 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/03/1976 | SUPPL-17 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/26/1977 | SUPPL-16 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/04/1977 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/16/1976 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/1976 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/09/1976 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1976 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/17/1976 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1976 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1975 | SUPPL-7 | 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 |
|---|---|---|---|---|---|
| 06/07/2021 | SUPPL-159 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017029s159lbl.pdf | |
| 07/02/2020 | SUPPL-156 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017029s156,017651s066lbl.pdf | |
| 11/16/2018 | SUPPL-141 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017029s141lbl.pdf | |
| 08/24/2017 | SUPPL-140 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017029s140lbl.pdf | |
| 12/23/2011 | SUPPL-131 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017029s131017651s055lbl.pdf | |
| 06/11/2010 | SUPPL-120 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.pdf | |
| 09/23/2008 | SUPPL-108 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017029s108lbl.pdf |
HEPARIN SODIUM
INJECTABLE;INJECTION; 1,000 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 | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214804 | BE PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205323 | GLAND |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017037 | HIKMA |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090571 | HOSPIRA INC |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203851 | MYLAN LABS LTD |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211005 | NANJING KING-FRIEND |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211007 | NANJING KING-FRIEND |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090808 | SAGENT PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091682 | SANDOZ |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202957 | SHENZHEN TECHDOW |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090810 | SAGENT PHARMS |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202732 | SHENZHEN TECHDOW |
INJECTABLE;INJECTION; 10,000 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 | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214839 | BE PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017037 | HIKMA |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090571 | HOSPIRA INC |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203851 | MYLAN LABS LTD |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211007 | NANJING KING-FRIEND |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090808 | SAGENT PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201002 | SANDOZ |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203198 | SHENZHEN TECHDOW |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 089522 | HOSPIRA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212060 | NANJING KING-FRIEND |
INJECTABLE;INJECTION; 20,000 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 | 20,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203852 | MYLAN LABS LTD |
| HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211004 | NANJING KING-FRIEND |
| HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090809 | SAGENT PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203198 | SHENZHEN TECHDOW |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%
There are no Therapeutic Equivalents.
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%
There are no Therapeutic Equivalents.
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%
There are no Therapeutic Equivalents.
HEPARIN SODIUM IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 1,000 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 | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214804 | BE PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205323 | GLAND |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017037 | HIKMA |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090571 | HOSPIRA INC |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203851 | MYLAN LABS LTD |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211005 | NANJING KING-FRIEND |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211007 | NANJING KING-FRIEND |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090808 | SAGENT PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091682 | SANDOZ |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202957 | SHENZHEN TECHDOW |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090810 | SAGENT PHARMS |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202732 | SHENZHEN TECHDOW |
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 |
INJECTABLE;INJECTION; 10,000 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 | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214839 | BE PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017037 | HIKMA |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090571 | HOSPIRA INC |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203851 | MYLAN LABS LTD |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211007 | NANJING KING-FRIEND |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090808 | SAGENT PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201002 | SANDOZ |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203198 | SHENZHEN TECHDOW |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 089522 | HOSPIRA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212060 | NANJING KING-FRIEND |
INJECTABLE;INJECTION; 20,000 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 | 20,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203852 | MYLAN LABS LTD |
| HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211004 | NANJING KING-FRIEND |
| HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090809 | SAGENT PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203198 | SHENZHEN TECHDOW |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
HEPARIN SODIUM PRESERVATIVE FREE
INJECTABLE;INJECTION; 10,000 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 | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214839 | BE PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017037 | HIKMA |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090571 | HOSPIRA INC |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203851 | MYLAN LABS LTD |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211007 | NANJING KING-FRIEND |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090808 | SAGENT PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201002 | SANDOZ |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203198 | SHENZHEN TECHDOW |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 089522 | HOSPIRA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212060 | NANJING KING-FRIEND |
INJECTABLE;INJECTION; 1,000 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 | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214804 | BE PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205323 | GLAND |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017037 | HIKMA |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090571 | HOSPIRA INC |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203851 | MYLAN LABS LTD |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211005 | NANJING KING-FRIEND |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211007 | NANJING KING-FRIEND |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090808 | SAGENT PHARMS |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091682 | SANDOZ |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202957 | SHENZHEN TECHDOW |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017029 | FRESENIUS KABI USA |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090810 | SAGENT PHARMS |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202732 | SHENZHEN TECHDOW |