Application 212994
- Type
- NDA
- Sponsor
- COMMCAVE THERAPEUTICS SA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AZSTARYS | SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE | CAPSULE;ORAL | 26.1MG/5.2MG | Yes | No |
| 002 | AZSTARYS | SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE | CAPSULE;ORAL | 39.2MG/7.8MG | Yes | No |
| 003 | AZSTARYS | SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE | CAPSULE;ORAL | 52.3MG/10.4MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65038-286 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
| 65038-286 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
| 65038-286 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
| 65038-286 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
| 65038-286 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
| 65038-429 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
| 65038-429 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
| 65038-429 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
| 65038-429 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
| 65038-429 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
| 65038-561 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
| 65038-561 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
| 65038-561 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
| 65038-561 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
| 65038-561 | AZSTARYS | Serdexmethylphenidate and Dexmethylphenidate | Corium, Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83506 | SUPPL | 2025-09-25 |
| 83505 | SUPPL | 2025-09-25 |
| 83464 | SUPPL | 2025-09-25 |
| 75890 | SUPPL | 2023-10-23 |
| 75891 | SUPPL | 2023-10-17 |
| 75859 | SUPPL | 2023-10-17 |
| 75827 | SUPPL | 2023-10-17 |
| 68936 | ORIG | 2021-10-08 |
| 66937 | ORIG | 2021-04-01 |
| 66497 | ORIG | 2021-03-04 |
| 66495 | ORIG | 2021-03-04 |
| 66493 | ORIG | 2021-03-04 |