Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209862
Company: KALEO INC
Company: KALEO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | 2MG/0.4ML (2MG/0.4ML) | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 10/19/2016 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/209862Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/209862Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/19/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf |