Application 021107
- Type
- NDA
- Sponsor
- SEBELA IRELAND LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LOTRONEX | ALOSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 1MG BASE | Yes | Yes |
| 002 | LOTRONEX | ALOSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 0.5MG BASE | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 45963-479 | Alosetron Hydrochloride | alosetron hydrochloride | Actavis Pharma, Inc. | NDA | Current |
| 45963-479 | Alosetron Hydrochloride | alosetron hydrochloride | Actavis Pharma, Inc. | NDA | Current |
| 45963-480 | Alosetron Hydrochloride | alosetron hydrochloride | Actavis Pharma, Inc. | NDA | Current |
| 45963-480 | Alosetron Hydrochloride | alosetron hydrochloride | Actavis Pharma, Inc. | NDA | Current |
| 54766-894 | LOTRONEX | alosetron hydrochloride | Sebela Pharmaceuticals Inc. | NDA | Current |
| 54766-894 | LOTRONEX | alosetron hydrochloride | Sebela Pharmaceuticals Inc. | NDA | Current |
| 54766-895 | LOTRONEX | alosetron hydrochloride | Sebela Pharmaceuticals Inc. | NDA | Current |
| 54766-895 | LOTRONEX | alosetron hydrochloride | Sebela Pharmaceuticals Inc. | NDA | Current |
| 65483-894 | LOTRONEX | alosetron hydrochloride | Prometheus Laboratories Inc. | NDA | Current |
| 65483-895 | LOTRONEX | alosetron hydrochloride | Prometheus Laboratories Inc. | NDA | Current |