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Application 208587
- Type
- NDA
- Sponsor
- EMMAUS MEDCL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ENDARI | L-GLUTAMINE | FOR SOLUTION;ORAL | 5GM/PACKET | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42457-420 | Endari | Glutamine | Emmaus Medical, Inc. | NDA | Current |
| 42457-420 | Endari | Glutamine | Emmaus Medical, Inc. | NDA | Current |
| 42457-420 | Endari | Glutamine | Emmaus Medical, Inc. | NDA | Current |
| 42457-420 | Endari | Glutamine | Emmaus Medical, Inc. | NDA | Current |
| 42457-420 | Endari | Glutamine | Emmaus Medical, Inc. | NDA | Current |
| 42457-420 | Endari | Glutamine | Emmaus Medical, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82617 | SUPPL | 2025-06-20 |
| 82608 | SUPPL | 2025-06-20 |
| 65118 | SUPPL | 2020-11-02 |
| 65083 | SUPPL | 2020-10-30 |
| 62654 | SUPPL | 2020-04-23 |
| 62647 | SUPPL | 2020-04-23 |
| 60786 | SUPPL | 2019-11-06 |
| 60783 | SUPPL | 2019-11-05 |
| 53646 | ORIG | 2018-04-10 |
| 48945 | ORIG | 2017-07-11 |
| 48926 | ORIG | 2017-07-07 |