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 DECATUR
Abbreviated New Drug Application (ANDA): 206319
Company: DECATUR
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 |
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 |
---|---|---|---|---|---|---|---|
11/13/2015 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/26/2018 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
07/22/2016 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
03/26/2018 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
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 |
منبع : www.accessdata.fda.gov
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