Application 050617
- Type
- NDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERYGEL | ERYTHROMYCIN | GEL;TOPICAL | 2% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-8075 | ERYGEL | erythromycin | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-8075 | ERYGEL | erythromycin | Mylan Pharmaceuticals Inc | NDA | Current |
| 0378-8212 | Erythromycin | erythromycin | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 40076-415 | ERYGEL | erythromycin | Prestium Pharma, Inc. | NDA | Current |
| 40076-415 | ERYGEL | erythromycin | Prestium Pharma, Inc. | NDA | Current |
| 40085-315 | Erythromycin | erythromycin | Renaissance Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |