Skip to contentApplication 202428
- Type
- NDA
- Sponsor
- MAYNE PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FABIOR | TAZAROTENE | AEROSOL, FOAM;TOPICAL | 0.1% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51862-295 | FABIOR | tazarotene | Mayne Pharma | NDA | Current |
| 51862-295 | FABIOR | tazarotene | Mayne Pharma | NDA | Current |
| 68308-685 | tazarotene | tazarotene | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44857 | ORIG | 2012-11-05 |
| 22889 | ORIG | 2012-11-05 |
| 10044 | ORIG | 2012-05-16 |
| 40179 | ORIG | 2012-05-15 |