اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER از شرکت HOSPIRA
New Drug Application (NDA): 018802
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACTERIOSTATIC 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 12/22/2016 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2014 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/23/1999 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/30/1997 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/19/1997 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/29/1996 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/1988 | SUPPL-6 | Manufacturing (CMC)-Control |
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. |
BACTERIOSTATIC 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 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 |
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