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
AMIKIN از شرکت APOTHECON
Abbreviated New Drug Application (ANDA): 062311
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMIKIN | AMIKACIN SULFATE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMIKIN | AMIKACIN SULFATE | EQ 250MG BASE/ML | 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 |
|---|---|---|---|---|---|---|---|
| 01/22/1981 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/17/2001 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/30/2000 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 07/31/1996 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 07/22/1993 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 11/16/1993 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1990 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1985 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1984 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/1983 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1983 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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