Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022119
Company: FEINSTEIN
Company: FEINSTEIN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMMONIA N 13 | AMMONIA N-13 | 30mCi-300mCi/8ML (3.75-37.5mCi/ML) | INJECTABLE;INTRAVENOUS | Prescription | AP | Yes | Yes |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/05/2011 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022119s001lbl.pdf |