Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | 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 |
|---|---|---|---|---|---|---|---|
| 06/08/1988 | 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 |
|---|---|---|---|---|---|
| 05/29/2019 | SUPPL-50 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2016 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019759s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019759Orig1s047ltr.pdf | |
| 06/10/2016 | SUPPL-46 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019465Orig1s054,019466Orig1s057,019479Orig1s049,019480Orig1s045,019759Orig1s046ltr.pdf |
| 11/01/2002 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/06/2000 | SUPPL-31 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/06/2000 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 04/06/2000 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/1997 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1997 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1999 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 03/04/1996 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1995 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/02/1990 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/01/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/06/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/01/2016 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019759s047lbl.pdf |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 450MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019635 | B BRAUN |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018016 | BAXTER HLTHCARE |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 208122 | FRESENIUS KABI USA |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019759 | HOSPIRA |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018090 | ICU MEDICAL INC |