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 MYLAN
Abbreviated New Drug Application (ANDA): 075188
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 02/24/1999 | ORIG-1 | Approval |
|
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone%20Hydrochloride_prntlbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/12/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/05/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/06/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/20/2002 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/21/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/24/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone%20Hydrochloride_prntlbl.pdf |
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