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 GLAND PHARMA LTD
Abbreviated New Drug Application (ANDA): 077161
Company: GLAND PHARMA LTD
| 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 |
|---|---|---|---|---|---|---|---|
| 04/20/2005 | 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 |
|---|---|---|---|---|---|
| 06/23/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/21/2013 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/30/2010 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/15/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/22/2008 | 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
نظرات کاربران