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
ADENOSINE از شرکت MYLAN ASI
Abbreviated New Drug Application (ANDA): 090212
Company: MYLAN ASI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription |
AP |
No | No |
| ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 03/28/2014 | 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 |
|---|---|---|---|---|---|
| 04/08/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
ADENOSINE
SOLUTION;INTRAVENOUS; 60MG/20ML (3MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 090450 | AKORN |
| ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205331 | AUROBINDO PHARMA LTD |
| ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 202313 | EMCURE PHARMS LTD |
| ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 077897 | FRESENIUS KABI USA |
| ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 203883 | HOSPIRA INC |
| ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 090212 | MYLAN ASI |
| ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 077425 | TEVA PHARMS USA |
SOLUTION;INTRAVENOUS; 90MG/30ML (3MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 090450 | AKORN |
| ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205331 | AUROBINDO PHARMA LTD |
| ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 202313 | EMCURE PHARMS LTD |
| ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 077897 | FRESENIUS KABI USA |
| ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 203883 | HOSPIRA INC |
| ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 090212 | MYLAN ASI |
| ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 077425 | TEVA PHARMS USA |
منبع : www.accessdata.fda.gov
نظرات کاربران