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 SAGENT PHARMS INC
Abbreviated New Drug Application (ANDA): 203323
Company: SAGENT PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 250MG BASE/ML | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
| AMIKACIN SULFATE | AMIKACIN SULFATE | 500MG(BASE)/ML(250MG/ML) | INJECTABLE;INJECTION | Prescription |
None |
TBD | No |
| AMIKACIN SULFATE | AMIKACIN SULFATE | 1G(BASE)/4ML(250MG/ML) | INJECTABLE;INJECTION | Prescription |
None |
TBD | 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 |
|---|---|---|---|---|---|---|---|
| 05/12/2016 | ORIG-1 | Approval |
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 |
|---|---|---|---|---|---|
| 05/12/2016 | SUPPL-12 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
AMIKACIN SULFATE
INJECTABLE;INJECTION; EQ 250MG 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 250MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204040 | EMCURE PHARMS LTD |
| AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 250MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205604 | FRESENIUS KABI USA |
| AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 250MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203323 | SAGENT PHARMS INC |
| AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 250MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 064045 | TEVA PHARMS USA |
| AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 250MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 063315 | WEST-WARD PHARMS INT |
منبع : www.accessdata.fda.gov
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