Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 10,000 UNITS/ML | 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 |
|---|---|---|---|---|---|---|---|
| 05/04/1987 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/13/2020 | SUPPL-56 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/06/2013 | SUPPL-47 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/23/2012 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/29/2014 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 01/14/2010 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/19/2010 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 05/08/2009 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 10/28/2008 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 02/14/2001 | SUPPL-15 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/09/1998 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/10/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1995 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/09/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/06/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/22/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/14/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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 |