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Application 215206
- Type
- NDA
- Sponsor
- ABBVIE INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | QULIPTA | ATOGEPANT | TABLET;ORAL | 10MG | Yes | No |
| 002 | QULIPTA | ATOGEPANT | TABLET;ORAL | 30MG | Yes | No |
| 003 | QULIPTA | ATOGEPANT | TABLET;ORAL | 60MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0074-7094 | Qulipta | Atogepant | AbbVie Inc. | NDA | Current |
| 0074-7094 | Qulipta | Atogepant | AbbVie Inc. | NDA | Current |
| 0074-7094 | Qulipta | Atogepant | AbbVie Inc. | NDA | Current |
| 0074-7095 | Qulipta | Atogepant | AbbVie Inc. | NDA | Current |
| 0074-7095 | Qulipta | Atogepant | AbbVie Inc. | NDA | Current |
| 0074-7095 | Qulipta | Atogepant | AbbVie Inc. | NDA | Current |
| 0074-7096 | Qulipta | Atogepant | AbbVie Inc. | NDA | Current |
| 0074-7096 | Qulipta | Atogepant | AbbVie Inc. | NDA | Current |
| 0074-7096 | Qulipta | Atogepant | AbbVie Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83627 | SUPPL | 2025-10-02 |
| 83622 | SUPPL | 2025-10-01 |
| 82549 | SUPPL | 2025-06-12 |
| 82548 | SUPPL | 2025-06-12 |
| 82533 | SUPPL | 2025-06-11 |
| 81716 | SUPPL | 2025-03-25 |
| 81697 | SUPPL | 2025-03-24 |
| 74017 | SUPPL | 2023-04-19 |
| 69181 | ORIG | 2021-11-01 |
| 68802 | ORIG | 2021-09-29 |
| 68801 | ORIG | 2021-09-29 |