Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088400
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 01/16/1984 | 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 |
|---|---|---|---|---|---|
| 11/23/2015 | SUPPL-30 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/21/2007 | SUPPL-25 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/08/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 07/12/2002 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/25/2001 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/02/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/21/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 05/29/1991 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1984 | SUPPL-1 | Manufacturing (CMC) |
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 |