Drugs@FDA: FDA-Approved Drugs
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | 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 |
|---|---|---|---|---|---|---|---|
| 02/18/1980 | 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 |
|---|---|---|---|---|---|
| 09/05/2013 | SUPPL-80 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/2007 | SUPPL-68 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018233s068ltr.pdf |
| 01/19/2005 | SUPPL-63 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18233s063ltr.pdf |
| 01/24/2003 | SUPPL-62 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18233scs062ltr.pdf |
| 10/15/2002 | SUPPL-61 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/04/1999 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1998 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/11/1997 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/2000 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 08/06/1996 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1996 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1996 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/1995 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/30/1991 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/28/1992 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/10/1991 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1987 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/26/1986 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1985 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1985 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 05/03/1985 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1985 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/26/1985 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/29/1985 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/29/1985 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/09/1984 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1983 | SUPPL-22 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/17/1984 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/21/1984 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/08/1983 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/10/1984 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/10/1984 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/26/1982 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1983 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1982 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/08/1982 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/09/1982 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/07/1981 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/12/1982 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/07/1981 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/15/1980 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1980 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/1980 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/14/1980 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
LIQUID;N/A; 100%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | Yes | AP | 018802 | HOSPIRA |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | No | AP | 209689 | FRESENIUS KABI USA |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | No | AP | 212735 | HIKMA |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | Yes | AP | 019633 | B BRAUN |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | Yes | AP | 018632 | BAXTER HLTHCARE |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | No | AP | 088400 | FRESENIUS KABI USA |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | Yes | AP | 018233 | ICU MEDICAL INC |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | Yes | AP | 019869 | ICU MEDICAL INC |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | No | AP | 077393 | TARO |