Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022027
Company: SCHERING
Company: SCHERING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NOXAFIL | POSACONAZOLE | 40MG/ML | SUSPENSION; 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 |
---|---|---|---|---|---|---|---|
10/20/2006 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | UNKNOWN |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022027s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022027_noxafil_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/21/2012 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf | |
06/21/2012 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf | |
09/08/2010 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022003s008,022027s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022003s008,022027s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/21/2012 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf | |
06/21/2012 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf | |
09/08/2010 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022003s008,022027s001lbl.pdf | |
10/20/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022027lbl.pdf |