Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020694
Company: JANSSEN PHARMA
Company: JANSSEN PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SPORANOX | ITRACONAZOLE | 100MG | CAPSULE; ORAL | Prescription | None | No | 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 |
---|---|---|---|---|---|---|---|
12/06/1996 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD; Orphan |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020694ap.pdf |