Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213792
Company: CURIUM
Company: CURIUM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IOFLUPANE I-123 | IOFLUPANE I-123 | 5mCi/2.5ML (2mCi/ML) | SOLUTION;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 |
---|---|---|---|---|---|---|---|
03/30/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213792Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/12/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
IOFLUPANE I-123
SOLUTION;INTRAVENOUS; 5mCi/2.5ML (2mCi/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DATSCAN | IOFLUPANE I-123 | 5mCi/2.5ML (2mCi/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 022454 | GE HLTHCARE INC |
IOFLUPANE I-123 | IOFLUPANE I-123 | 5mCi/2.5ML (2mCi/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213792 | CURIUM |