Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (1ML) | LIQUID;N/A | Discontinued | None | Yes | No |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID;N/A | Prescription | AP | Yes | Yes |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID;N/A | Prescription | AP | Yes | Yes |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (50ML) | LIQUID;N/A | Prescription | None | Yes | Yes |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (100ML) | LIQUID;N/A | Prescription | None | Yes | Yes |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (5.2ML) | LIQUID;N/A | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 10/27/1982 | 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 |
|---|---|---|---|---|---|
| 12/21/2016 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/2016 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2014 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/2014 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/2009 | SUPPL-34 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018801s034ltr.pdf |
| 04/07/2004 | SUPPL-23 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18801scs023ltr.pdf |
| 02/16/2001 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/04/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/2000 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/28/1999 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/27/1999 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/1999 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/14/1998 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/13/1998 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/29/1996 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/17/1997 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1996 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/14/1989 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/21/1988 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1985 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/1985 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/17/1984 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/1984 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/25/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
STERILE WATER FOR INJECTION
LIQUID;N/A; 100% (10ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID;N/A | Prescription | No | AP | 217341 | AM REGENT |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID;N/A | Prescription | No | AP | 206369 | HIKMA |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID;N/A | Prescription | Yes | AP | 018801 | HOSPIRA |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID;N/A | Prescription | No | AP | 211188 | MEDEFIL INC |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID;N/A | Prescription | No | AP | 217536 | NEXUS |
LIQUID;N/A; 100% (20ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID;N/A | Prescription | No | AP | 217341 | AM REGENT |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID;N/A | Prescription | Yes | AP | 018801 | HOSPIRA |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID;N/A | Prescription | No | AP | 217536 | NEXUS |