Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202428
Company: MAYNE PHARMA
Company: MAYNE PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FABIOR | TAZAROTENE | 0.1% | AEROSOL, FOAM;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 |
---|---|---|---|---|---|---|---|
05/11/2012 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202428lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202428s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202428_fabior_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202428Orig1s000SumR.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/11/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202428lbl.pdf |