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
AMIKACIN SULFATE از شرکت WEST-WARD PHARMS INT
Abbreviated New Drug Application (ANDA): 063313
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription |
AP |
No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/11/1994 | 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 |
|---|---|---|---|---|---|
| 11/20/2012 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/03/2001 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/04/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
AMIKACIN SULFATE
INJECTABLE;INJECTION; EQ 50MG BASE/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205605 | FRESENIUS KABI USA |
| AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 063313 | WEST-WARD PHARMS INT |
منبع : www.accessdata.fda.gov
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