Application 022055
- Type
- NDA
- Sponsor
- ALMIRALL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALTABAX | RETAPAMULIN | OINTMENT;TOPICAL | 1% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16110-518 | Altabax | retapamulin | Aqua Pharmaceuticals, LLC | NDA | Current |
| 16110-518 | Altabax | retapamulin | Almirall, LLC | NDA | Current |
| 16110-518 | Altabax | retapamulin | Almirall, LLC | NDA | Current |
| 16110-518 | Altabax | retapamulin | Almirall, LLC | NDA | Current |
| 21695-644 | Altabax | retapamulin | Rebel Distributors Corp. | NDA | Current |