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Application 204048
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RILUZOLE | RILUZOLE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67877-286 | Riluzole | Riluzole | Ascend Laboratories, LLC | ANDA | Current |
| 67877-286 | Riluzole | Riluzole | Ascend Laboratories, LLC | ANDA | Current |
| 67877-286 | Riluzole | Riluzole | Ascend Laboratories, LLC | ANDA | Current |