Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
| 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 | Prescription | AP | Yes | Yes |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/0.5ML | 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 |
|---|---|---|---|---|---|---|---|
| 03/22/1972 | 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 |
|---|---|---|---|---|---|
| 01/14/2020 | SUPPL-187 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017037Orig1s187lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017037Orig1s187ltr.pdf | |
| 05/18/2019 | SUPPL-183 | Manufacturing (CMC)-Formulation |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017037Orig1s183lbl.pdf | |
| 05/09/2017 | SUPPL-178 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017037s178lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017037Orig1s178ltr.pdf | |
| 10/30/2015 | SUPPL-176 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/2015 | SUPPL-175 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/2015 | SUPPL-174 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/2015 | SUPPL-173 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/2014 | SUPPL-172 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/2014 | SUPPL-171 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/2013 | SUPPL-170 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/2011 | SUPPL-169 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s169.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017037s169ltr.pdf | |
| 02/23/2011 | SUPPL-168 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s168lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017037s168ltr.pdf | |
| 10/01/2009 | SUPPL-165 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017037s165lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017037s165ltr.pdf | |
| 02/17/2009 | SUPPL-162 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017037s162ltr.pdf |
| 12/14/2007 | SUPPL-161 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017037s161lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017037s161ltr.pdf | |
| 10/04/2006 | SUPPL-158 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017037s158lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017037s158LTR.pdf | |
| 09/02/2005 | SUPPL-156 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017037s154,055,156ltr.pdf | |
| 09/02/2005 | SUPPL-155 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017037s154,055,156ltr.pdf | |
| 09/02/2005 | SUPPL-154 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017037s154,055,156ltr.pdf | |
| 11/22/2002 | SUPPL-151 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/25/2002 | SUPPL-150 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/21/2002 | SUPPL-149 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/22/2002 | SUPPL-148 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/15/2002 | SUPPL-147 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/05/2002 | SUPPL-146 | Labeling |
Label is not available on this site. |
||
| 08/31/2001 | SUPPL-145 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/16/2000 | SUPPL-144 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/31/2000 | SUPPL-143 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/2000 | SUPPL-142 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/2000 | SUPPL-141 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/2000 | SUPPL-140 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/2000 | SUPPL-139 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/13/1999 | SUPPL-138 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1999 | SUPPL-136 | Labeling |
Label is not available on this site. |
||
| 02/20/1998 | SUPPL-134 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/23/1998 | SUPPL-133 | Labeling |
Label is not available on this site. |
||
| 04/24/1997 | SUPPL-132 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1996 | SUPPL-131 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1993 | SUPPL-130 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/1991 | SUPPL-128 | Labeling |
Label is not available on this site. |
||
| 09/27/1989 | SUPPL-127 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/20/1989 | SUPPL-126 | Labeling |
Label is not available on this site. |
||
| 06/20/1989 | SUPPL-125 | Labeling |
Label is not available on this site. |
||
| 06/28/1989 | SUPPL-124 | Labeling |
Label is not available on this site. |
||
| 10/14/1987 | SUPPL-123 | Labeling |
Label is not available on this site. |
||
| 09/16/1987 | SUPPL-122 | Labeling |
Label is not available on this site. |
||
| 07/02/1987 | SUPPL-121 | Labeling |
Label is not available on this site. |
||
| 07/02/1987 | SUPPL-120 | Labeling |
Label is not available on this site. |
||
| 04/24/1987 | SUPPL-119 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/10/1987 | SUPPL-118 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1987 | SUPPL-117 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/23/1986 | SUPPL-116 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1987 | SUPPL-115 | Labeling |
Label is not available on this site. |
||
| 01/30/1986 | SUPPL-114 | Labeling |
Label is not available on this site. |
||
| 10/10/1985 | SUPPL-113 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1986 | SUPPL-112 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/29/1985 | SUPPL-111 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/29/1985 | SUPPL-110 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/13/1985 | SUPPL-109 | Labeling |
Label is not available on this site. |
||
| 01/21/1986 | SUPPL-108 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/11/1984 | SUPPL-107 | Labeling |
Label is not available on this site. |
||
| 10/11/1984 | SUPPL-105 | Labeling |
Label is not available on this site. |
||
| 08/02/1984 | SUPPL-104 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/21/1983 | SUPPL-102 | Labeling |
Label is not available on this site. |
||
| 09/05/1983 | SUPPL-101 | Labeling |
Label is not available on this site. |
||
| 06/10/1983 | SUPPL-100 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1983 | SUPPL-99 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/06/1982 | SUPPL-98 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1982 | SUPPL-97 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/04/1982 | SUPPL-96 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1981 | SUPPL-95 | Labeling |
Label is not available on this site. |
||
| 05/22/1981 | SUPPL-94 | Labeling |
Label is not available on this site. |
||
| 01/21/1980 | SUPPL-93 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1979 | SUPPL-92 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/06/1979 | SUPPL-91 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/1979 | SUPPL-90 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/1979 | SUPPL-89 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/1979 | SUPPL-88 | Labeling |
Label is not available on this site. |
||
| 10/04/1978 | SUPPL-87 | Labeling |
Label is not available on this site. |
||
| 08/04/1978 | SUPPL-86 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1978 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 08/04/1978 | SUPPL-84 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1978 | SUPPL-83 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1978 | SUPPL-82 | Labeling |
Label is not available on this site. |
||
| 12/14/1977 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 12/14/1977 | SUPPL-80 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/1977 | SUPPL-79 | Labeling |
Label is not available on this site. |
||
| 04/27/1978 | SUPPL-78 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/27/1978 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 12/14/1977 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 12/14/1977 | SUPPL-74 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/03/1978 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1977 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 05/26/1977 | SUPPL-71 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/1977 | SUPPL-70 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/26/1977 | SUPPL-69 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/17/1977 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/19/1976 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
| 10/19/1976 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 09/08/1976 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1976 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1976 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1976 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1976 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1976 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 09/03/1976 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 09/03/1976 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 01/09/1976 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/04/1975 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 09/04/1975 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 09/04/1975 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 09/04/1975 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 09/04/1975 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 09/04/1975 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 04/23/1975 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/24/1975 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 03/05/1984 | SUPPL-13 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/14/2020 | SUPPL-187 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017037Orig1s187lbl.pdf | |
| 05/18/2019 | SUPPL-183 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017037Orig1s183lbl.pdf | |
| 05/09/2017 | SUPPL-178 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017037s178lbl.pdf | |
| 12/23/2011 | SUPPL-169 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s169.pdf | |
| 02/23/2011 | SUPPL-168 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s168lbl.pdf | |
| 10/01/2009 | SUPPL-165 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017037s165lbl.pdf | |
| 12/14/2007 | SUPPL-161 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017037s161lbl.pdf | |
| 10/04/2006 | SUPPL-158 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017037s158lbl.pdf | |
| 09/02/2005 | SUPPL-156 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf | |
| 09/02/2005 | SUPPL-155 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf | |
| 09/02/2005 | SUPPL-154 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.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; 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; 5,000 UNITS/0.5ML
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/0.5ML | INJECTABLE;INJECTION | Prescription | No | AP | 208827 | B BRAUN MEDICAL INC |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/0.5ML | INJECTABLE;INJECTION | Prescription | No | AP | 017037 | HIKMA |