Application 211601
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TASIMELTEON | TASIMELTEON | CAPSULE; ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0480-4490 | Tasimelteon | Tasimelteon | Teva Pharmaceuticals, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 68925 | ORIG | 2021-10-08 |