Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019633
Company: B BRAUN
Company: B BRAUN
| 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 |
|---|---|---|---|---|---|---|---|
| 02/29/1988 | 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 |
|---|---|---|---|---|---|
| 08/29/2014 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/2003 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 07/01/2002 | SUPPL-17 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/15/2002 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-14 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/15/2000 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/21/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1988 | SUPPL-1 | Labeling |
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 |