Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021026
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VUSION | MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE | 0.25%;81.35%;15% | OINTMENT;TOPICAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/16/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021026s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021026_vusion_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/29/2018 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021026s013lbl.pdf | |
06/16/2016 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/21/2014 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/01/2010 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021026s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021026s006ltr.pdf | |
10/03/2007 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021026s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021026s004ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/29/2018 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021026s013lbl.pdf | |
04/01/2010 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021026s006lbl.pdf | |
10/03/2007 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021026s004lbl.pdf | |
02/16/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021026s000lbl.pdf |