Home Applications 215153 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215153-001 VOQUEZNA DUAL PAK AMOXICILLIN; VONOPRAZAN FUMARATE 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215153-001 7977488 2030-04-10 Drug substance 2022-07-27 N215153-001 9186411 2030-08-11 Drug product 2022-07-27
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215153-001 NCE 2027-05-03 N215153-001 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 table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD 2022-05-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD 2022-05-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD 2022-05-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD 2022-05-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD 2022-05-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD 2022-05-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 58 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N215153-001 7977488 2030-04-10 Drug substance 2022-07-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215153-001 7977488 2030-04-10 Drug substance 2022-07-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215153-001 7977488 2030-04-10 Drug substance 2022-07-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 a72a2bbeb626…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 62 observed states.
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
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