Application 207994
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68382-912 | Fingolimod | Fingolimod | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70771-1603 | Fingolimod | Fingolimod | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1603 | Fingolimod | Fingolimod | Zydus Lifesciences Limited | ANDA | Current |