Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206319
Company: DECATUR
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 |