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 10% IN PLASTIC CONTAINER از شرکت ICU MEDICAL INC
New Drug Application (NDA): 020015
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOSYN II 10% IN PLASTIC CONTAINER | AMINO ACIDS | 10% (10GM/100ML) | INJECTABLE;INJECTION | Prescription |
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 |
|---|---|---|---|---|---|---|---|
| 12/19/1991 | 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 |
|---|---|---|---|---|---|
| 09/15/2014 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/2011 | SUPPL-28 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/13/2003 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/30/2003 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/01/2002 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/05/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
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