Application 215152
- Type
- NDA
- Sponsor
- PHATHOM PHARMACEUTICALS, INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VOQUEZNA TRIPLE PAK | AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN | CAPSULE, TABLET, TABLET | 500MG; 500MG; 20MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 81520-255 | VOQUEZNA TRIPLE PAK | vonoprazan fumarate, amoxicillin and clarithromycin | Phathom Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85766 | SUPPL | 2026-04-27 |
| 85764 | SUPPL | 2026-04-27 |
| 84042 | SUPPL | 2025-11-04 |
| 84040 | SUPPL | 2025-11-03 |
| 82572 | SUPPL | 2025-06-13 |
| 82565 | SUPPL | 2025-06-13 |
| 79281 | SUPPL | 2024-08-02 |
| 79271 | SUPPL | 2024-08-02 |
| 78382 | SUPPL | 2024-05-03 |
| 75129 | SUPPL | 2023-08-19 |
| 75106 | SUPPL | 2023-08-17 |
| 71255 | ORIG | 2022-06-08 |
| 71011 | ORIG | 2022-05-06 |
| 70991 | ORIG | 2022-05-04 |