Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203994
Company: NORTHLAND
Company: NORTHLAND
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 4-500mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
02/04/2015 | ORIG-1 | Approval |
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