Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022484
Company: SEBELA IRELAND LTD
Company: SEBELA IRELAND LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ONMEL | ITRACONAZOLE | 200MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
04/29/2010 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022484S000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022484s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022484s000_itraconazole__toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022484Orig1s000SumR.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/29/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022484S000lbl.pdf |