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
CHOLINE C-11 از شرکت MCPRF
New Drug Application (NDA): 203155
Company: MCPRF
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHOLINE C-11 | CHOLINE C-11 | 4-33.1mCi/ML | INJECTABLE;INTRAVENOUS | Prescription |
AP |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/12/2012 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203155s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/16/2014 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/2015 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/2015 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/2013 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/12/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203155s000lbl.pdf |
CHOLINE C-11
INJECTABLE;INTRAVENOUS; 4-33.1mCi/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHOLINE C-11 | CHOLINE C-11 | 4-33.1mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206319 | DECATUR |
| CHOLINE C-11 | CHOLINE C-11 | 4-33.1mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 203155 | MCPRF |
| CHOLINE C-11 | CHOLINE C-11 | 4-33.1mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 208413 | WA UNIV SCH MED |
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