Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021464
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VFEND | VORICONAZOLE | 50MG | Tablet; Oral | Prescription | None | No | No |
VFEND | VORICONAZOLE | 200MG | Tablet; Oral | Prescription | None | No | No |
VFEND | VORICONAZOLE | 200MG | Injectable; Injection | 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 |
---|---|---|---|---|---|---|---|
11/14/2003 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021466lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21464,21466ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021464s000_021466s000_VfendTOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/14/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021466lbl.pdf |