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
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER از شرکت HOSPIRA INC
New Drug Application (NDA): 019683
Company: HOSPIRA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 4.25%;36.8MG/100ML;20GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 4.25%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | INJECTABLE;INJECTION | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 11/07/1988 | 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 |
|---|---|---|---|---|---|
| 10/05/2005 | SUPPL-27 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019683s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019683s027ltr.pdf |
||
| 01/31/2003 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19683scs021ltr.pdf |
|
| 11/08/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/2003 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/29/1998 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/1998 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/1997 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/11/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1997 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1996 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1997 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/18/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1993 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1991 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/28/1992 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/18/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/05/2005 | SUPPL-27 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019683s027lbl.pdf |
نظرات کاربران