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
AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE از شرکت HOSPIRA
New Drug Application (NDA): 018901
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE | AMINO ACIDS | 5.2% (5.2GM/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 |
|---|---|---|---|---|---|---|---|
| 04/06/1984 | 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 |
|---|---|---|---|---|---|
| 12/21/1999 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/25/1994 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/05/1990 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/05/1990 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/10/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1988 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/27/1984 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1985 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1984 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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