Application 215153
- Type
- NDA
- Sponsor
- PHATHOM PHARMACEUTICALS, INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VOQUEZNA DUAL PAK | AMOXICILLIN, VONOPRAZAN | CAPSULE, TABLET | 500MG; 20MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 81520-250 | VOQUEZNA DUAL PAK | vonoprazan fumarate and amoxicillin | Phathom Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84060 | SUPPL | 2025-11-04 |
| 84043 | SUPPL | 2025-11-04 |
| 82573 | SUPPL | 2025-06-13 |
| 82566 | SUPPL | 2025-06-13 |
| 79282 | SUPPL | 2024-08-02 |
| 79273 | SUPPL | 2024-08-02 |
| 78383 | SUPPL | 2024-05-03 |
| 75130 | SUPPL | 2023-08-18 |
| 75107 | SUPPL | 2023-08-17 |
| 71256 | ORIG | 2022-06-08 |
| 71042 | ORIG | 2022-05-06 |
| 70992 | ORIG | 2022-05-04 |