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 15% IN PLASTIC CONTAINER از شرکت ICU MEDICAL INC
New Drug Application (NDA): 020041
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOSYN II 15% IN PLASTIC CONTAINER | AMINO ACIDS | 15% (15GM/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 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 04/27/2007 | SUPPL-20 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/27/2003 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20041scs013ltr.pdf |
|
| 11/08/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-11 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20041slr011ltr.pdf |
|
| 05/05/1997 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1996 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1997 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/1995 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1995 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/17/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
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