Application 208342
- Type
- ANDA
- Sponsor
- AMERIGEN PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MIGLUSTAT | MIGLUSTAT | CAPSULE;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43975-310 | MIGLUSTAT | MIGLUSTAT | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 43975-310 | MIGLUSTAT | MIGLUSTAT | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 43975-310 | MIGLUSTAT | MIGLUSTAT | Amerigen Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 53758 | ORIG | 2018-04-20 |