Application 208004
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FINGOLIMOD | FINGOLIMOD | CAPSULE;ORAL | 0.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67877-476 | Fingolimod | Fingolimod hydrochloride | Ascend Laboratories, LLC | ANDA | Current |