Application 215152
- Type
- NDA
- Sponsor
- PHATHOM PHARMACEUTICALS, INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VOQUEZNA TRIPLE PAK | AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN | CAPSULE, TABLET, TABLET | 500MG; 500MG; 20MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N215152-001 | VOQUEZNA TRIPLE PAK | AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N215152-001 | 7977488 | 2030-04-10 | Drug substance | 2022-07-27 | |
| N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N215152-001 | NCE | 2027-05-03 |
| N215152-001 | GAIN | 2032-05-03 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 5c6f7cd8ea54… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD | 2022-05-03 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD | 2022-05-03 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD | 2022-05-03 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD | 2022-05-03 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD | 2022-05-03 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD | 2022-05-03 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N215152-001 | 7977488 | 2030-04-10 | Drug substance | 2022-07-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | a67488948f0b… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N215152-001 | NCE | 2027-05-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215152-001 | GAIN | 2032-05-03 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215152-001 | NCE | 2027-05-03 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215152-001 | GAIN | 2032-05-03 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N215152-001 | NCE | 2027-05-03 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215152-001 | GAIN | 2032-05-03 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215152-001 | NCE | 2027-05-03 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215152-001 | GAIN | 2032-05-03 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215152-001 | NCE | 2027-05-03 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215152-001 | GAIN | 2032-05-03 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215152-001 | NCE | 2027-05-03 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215152-001 | GAIN | 2032-05-03 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215152-001 | NCE | 2027-05-03 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215152-001 | GAIN | 2032-05-03 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215152-001 | NCE | 2027-05-03 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215152-001 | GAIN | 2032-05-03 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215152-001 | NCE | 2027-05-03 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215152-001 | GAIN | 2032-05-03 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N215152-001 | NCE | 2027-05-03 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N215152-001 | GAIN | 2032-05-03 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215152-001 | NCE | 2027-05-03 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215152-001 | GAIN | 2032-05-03 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215152-001 | NCE | 2027-05-03 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215152-001 | GAIN | 2032-05-03 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215152-001 | NCE | 2027-05-03 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215152-001 | GAIN | 2032-05-03 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N215152-001 | NCE | 2027-05-03 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N215152-001 | GAIN | 2032-05-03 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N215152-001 | NCE | 2027-05-03 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N215152-001 | GAIN | 2032-05-03 | 5c6f7cd8ea54… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215152-001 | NCE | 2027-05-03 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215152-001 | GAIN | 2032-05-03 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N215152-001 | NCE | 2027-05-03 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N215152-001 | GAIN | 2032-05-03 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N215152-001 | NCE | 2027-05-03 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N215152-001 | GAIN | 2032-05-03 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215152-001 | NCE | 2027-05-03 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215152-001 | GAIN | 2032-05-03 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215152-001 | NCE | 2027-05-03 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215152-001 | GAIN | 2032-05-03 | 9b2671bbb829… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| VOQUEZNA DUAL PAK | VONOPRAZAN FUMARATE AND AMOXICILLIN | Phathom Pharmaceuticals Inc. | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 2026-07-16 | Warnings, Adverse reactions | 215152 NDA215152 81520-255 |
NDC Listings For This Application#
| 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 |
|---|---|---|
| 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 |