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
AMIODARONE HYDROCHLORIDE از شرکت FRESENIUS KABI USA
Abbreviated New Drug Application (ANDA): 075761
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 50MG/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 |
|---|---|---|---|---|---|---|---|
| 10/15/2002 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75761.TA.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/04/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/22/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/21/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/20/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/24/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
AMIODARONE HYDROCHLORIDE
INJECTABLE;INJECTION; 50MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204550 | AUROBINDO PHARMA LTD |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075761 | FRESENIUS KABI USA |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077161 | GLAND PHARMA LTD |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077234 | HIKMA FARMACEUTICA |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203884 | HOSPIRA INC |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203885 | HOSPIRA INC |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076217 | MYLAN INSTITUTIONAL |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077610 | WOCKHARDT |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077834 | WOCKHARDT |
منبع : www.accessdata.fda.gov
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