Home Applications 217159 Application 217159
Type NDA
Sponsor AYRMID PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 APHEXDA MOTIXAFORTIDE ACETATE POWDER;SUBCUTANEOUS EQ 62MG BASE/VIAL Yes Yes
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 N217159-001 APHEXDA MOTIXAFORTIDE ACETATE EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08
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 N217159-001 12257285 2041-12-29 Drug product 2025-04-10 N217159-001 12268725 2041-12-29 Drug product 2025-04-10
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217159-001 NCE 2028-09-08 N217159-001 ODE-442 2030-09-08
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 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 a50c72e98297…
Observed Orange Book patent history# 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 N217159-001 12257285 2041-12-29 Drug product 2025-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217159-001 12268725 2041-12-29 Drug product 2025-04-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217159-001 12257285 2041-12-29 Drug product 2025-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217159-001 12268725 2041-12-29 Drug product 2025-04-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217159-001 12257285 2041-12-29 Drug product 2025-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217159-001 12268725 2041-12-29 Drug product 2025-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217159-001 12257285 2041-12-29 Drug product 2025-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217159-001 12268725 2041-12-29 Drug product 2025-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217159-001 12257285 2041-12-29 Drug product 2025-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217159-001 12268725 2041-12-29 Drug product 2025-04-10 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217159-001 12257285 2041-12-29 Drug product 2025-04-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217159-001 12268725 2041-12-29 Drug product 2025-04-10 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 42 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 · 2 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 85368 SUPPL 2026-03-12 85360 SUPPL 2026-03-12 75522 ORIG 2023-09-21 75441 ORIG 2023-09-13 75390 ORIG 2023-09-11