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 GLAND PHARMA LTD
Abbreviated New Drug Application (ANDA): 077283
Company: GLAND PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 06/14/2007 | 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 |
|---|---|---|---|---|---|
| 11/20/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/14/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/14/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
ADENOSINE
INJECTABLE;INJECTION; 3MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078076 | AKORN |
| ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077133 | FRESENIUS KABI USA |
| ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205568 | FRESENIUS KABI USA |
| ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077283 | GLAND PHARMA LTD |
| ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206778 | GLAND PHARMA LTD |
| ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078686 | MYLAN LABS LTD |
| ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076404 | WEST-WARD PHARMS INT |
| ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076500 | WEST-WARD PHARMS INT |
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