Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| 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 |
| 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 |
|---|---|---|---|---|---|---|---|
| 06/30/1982 | 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 |
|---|---|---|---|---|---|
| 05/26/2016 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018632s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018632Orig1s051ltr.pdf | |
| 09/26/2014 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/2006 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 05/11/2005 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 01/23/2004 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 08/29/2001 | SUPPL-33 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/02/1999 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 07/28/1998 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 07/15/1997 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1995 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1993 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1992 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 05/18/1990 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1989 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1987 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/16/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1986 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/09/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1984 | SUPPL-2 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/26/2016 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018632s051lbl.pdf |
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 |
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 |