Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020314
Company: CURIUM
Company: CURIUM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OCTREOSCAN | INDIUM IN-111 PENTETREOTIDE KIT | 3mCi/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/09/2022 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020314Orig1s012lbl.pdf | |
12/22/2021 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020314S014lbl.pdf |