Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016367
Company: OTSUKA ICU MEDCL
Company: OTSUKA ICU MEDCL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/09/2025 | SUPPL-231 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/016367s231,018080s122lbl.pdf | |
| 10/26/2006 | SUPPL-182 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016367s182lbl.pdf | |
| 09/02/2005 | SUPPL-178 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016367s178lbl.pdf |