Home Applications 214927 Application 214927
Type NDA
Sponsor ZEVRA DENMARK Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MIPLYFFA ARIMOCLOMOL CITRATE CAPSULE;ORAL EQ 47MG BASE Yes No 002 MIPLYFFA ARIMOCLOMOL CITRATE CAPSULE;ORAL EQ 62MG BASE Yes No 003 MIPLYFFA ARIMOCLOMOL CITRATE CAPSULE;ORAL EQ 93MG BASE Yes No 004 MIPLYFFA ARIMOCLOMOL CITRATE CAPSULE;ORAL EQ 124MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214927-001 MIPLYFFA ARIMOCLOMOL CITRATE EQ 47MG BASE CAPSULE / ORAL RLD 2024-09-20 N214927-002 MIPLYFFA ARIMOCLOMOL CITRATE EQ 62MG BASE CAPSULE / ORAL RLD 2024-09-20 N214927-003 MIPLYFFA ARIMOCLOMOL CITRATE EQ 93MG BASE CAPSULE / ORAL RLD 2024-09-20 N214927-004 MIPLYFFA ARIMOCLOMOL CITRATE EQ 124MG BASE CAPSULE / ORAL RLD, RS 2024-09-20
Orange Book patents# Current patent rows page 1 of 1 · 16 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214927-001 9884058 2029-06-26 U-4021 2024-10-21 N214927-001 9289472 2029-08-11 U-4021 2024-10-21 N214927-001 11045460 2029-08-19 U-4021 2024-10-21 N214927-001 11707456 2041-11-19 U-4021 Drug substance, Drug product 2026-06-05 N214927-002 9884058 2029-06-26 U-4021 2024-10-21 N214927-002 9289472 2029-08-11 U-4021 2024-10-21 N214927-002 11045460 2029-08-19 U-4021 2024-10-21 N214927-002 11707456 2041-11-19 U-4021 Drug substance, Drug product 2026-06-05 N214927-003 9884058 2029-06-26 U-4021 2024-10-21 N214927-003 9289472 2029-08-11 U-4021 2024-10-21 N214927-003 11045460 2029-08-19 U-4021 2024-10-21 N214927-003 11707456 2041-11-19 U-4021 Drug substance, Drug product 2026-06-05 N214927-004 9884058 2029-06-26 U-4021 2024-10-21 N214927-004 9289472 2029-08-11 U-4021 2024-10-21 N214927-004 11045460 2029-08-19 U-4021 2024-10-21 N214927-004 11707456 2041-11-19 U-4021 Drug substance, Drug product 2026-06-05
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 matching rows.
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 2026-02-19 14:30 UTC 2026-02 N214927-001 MIPLYFFA EQ 47MG BASE CAPSULE / ORAL RLD 2024-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214927-002 MIPLYFFA EQ 62MG BASE CAPSULE / ORAL RLD 2024-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214927-003 MIPLYFFA EQ 93MG BASE CAPSULE / ORAL RLD 2024-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214927-004 MIPLYFFA EQ 124MG BASE CAPSULE / ORAL RLD, RS 2024-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-001 MIPLYFFA EQ 47MG BASE CAPSULE / ORAL RLD 2024-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-002 MIPLYFFA EQ 62MG BASE CAPSULE / ORAL RLD 2024-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-003 MIPLYFFA EQ 93MG BASE CAPSULE / ORAL RLD 2024-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-004 MIPLYFFA EQ 124MG BASE CAPSULE / ORAL RLD, RS 2024-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214927-001 MIPLYFFA EQ 47MG BASE CAPSULE / ORAL RLD 2024-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214927-002 MIPLYFFA EQ 62MG BASE CAPSULE / ORAL RLD 2024-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214927-003 MIPLYFFA EQ 93MG BASE CAPSULE / ORAL RLD 2024-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214927-004 MIPLYFFA EQ 124MG BASE CAPSULE / ORAL RLD, RS 2024-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214927-001 MIPLYFFA EQ 47MG BASE CAPSULE / ORAL RLD 2024-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214927-002 MIPLYFFA EQ 62MG BASE CAPSULE / ORAL RLD 2024-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214927-003 MIPLYFFA EQ 93MG BASE CAPSULE / ORAL RLD 2024-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214927-004 MIPLYFFA EQ 124MG BASE CAPSULE / ORAL RLD, RS 2024-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214927-001 MIPLYFFA EQ 47MG BASE CAPSULE / ORAL RLD 2024-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214927-002 MIPLYFFA EQ 62MG BASE CAPSULE / ORAL RLD 2024-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214927-003 MIPLYFFA EQ 93MG BASE CAPSULE / ORAL RLD 2024-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214927-004 MIPLYFFA EQ 124MG BASE CAPSULE / ORAL RLD, RS 2024-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214927-001 MIPLYFFA EQ 47MG BASE CAPSULE / ORAL RLD 2024-09-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214927-002 MIPLYFFA EQ 62MG BASE CAPSULE / ORAL RLD 2024-09-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214927-003 MIPLYFFA EQ 93MG BASE CAPSULE / ORAL RLD 2024-09-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214927-004 MIPLYFFA EQ 124MG BASE CAPSULE / ORAL RLD, RS 2024-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214927-001 MIPLYFFA EQ 47MG BASE CAPSULE / ORAL RLD 2024-09-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214927-002 MIPLYFFA EQ 62MG BASE CAPSULE / ORAL RLD 2024-09-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214927-003 MIPLYFFA EQ 93MG BASE CAPSULE / ORAL RLD 2024-09-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214927-004 MIPLYFFA EQ 124MG BASE CAPSULE / ORAL RLD, RS 2024-09-20 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214927-001 MIPLYFFA EQ 47MG BASE CAPSULE / ORAL RLD 2024-09-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214927-002 MIPLYFFA EQ 62MG BASE CAPSULE / ORAL RLD 2024-09-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214927-003 MIPLYFFA EQ 93MG BASE CAPSULE / ORAL RLD 2024-09-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214927-004 MIPLYFFA EQ 124MG BASE CAPSULE / ORAL RLD, RS 2024-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214927-001 MIPLYFFA EQ 47MG BASE CAPSULE / ORAL RLD 2024-09-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214927-002 MIPLYFFA EQ 62MG BASE CAPSULE / ORAL RLD 2024-09-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214927-003 MIPLYFFA EQ 93MG BASE CAPSULE / ORAL RLD 2024-09-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214927-004 MIPLYFFA EQ 124MG BASE CAPSULE / ORAL RLD, RS 2024-09-20 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214927-001 MIPLYFFA EQ 47MG BASE CAPSULE / ORAL RLD 2024-09-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214927-002 MIPLYFFA EQ 62MG BASE CAPSULE / ORAL RLD 2024-09-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214927-003 MIPLYFFA EQ 93MG BASE CAPSULE / ORAL RLD 2024-09-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214927-004 MIPLYFFA EQ 124MG BASE CAPSULE / ORAL RLD, RS 2024-09-20 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 112 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214927-001 9884058 2029-06-26 U-4021 2024-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214927-001 9289472 2029-08-11 U-4021 2024-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214927-001 11045460 2029-08-19 U-4021 2024-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214927-002 9884058 2029-06-26 U-4021 2024-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214927-002 9289472 2029-08-11 U-4021 2024-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214927-002 11045460 2029-08-19 U-4021 2024-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214927-003 9884058 2029-06-26 U-4021 2024-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214927-003 9289472 2029-08-11 U-4021 2024-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214927-003 11045460 2029-08-19 U-4021 2024-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214927-004 9884058 2029-06-26 U-4021 2024-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214927-004 9289472 2029-08-11 U-4021 2024-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214927-004 11045460 2029-08-19 U-4021 2024-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-001 9884058 2029-06-26 U-4021 2024-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-001 9289472 2029-08-11 U-4021 2024-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-001 11045460 2029-08-19 U-4021 2024-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-002 9884058 2029-06-26 U-4021 2024-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-002 9289472 2029-08-11 U-4021 2024-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-002 11045460 2029-08-19 U-4021 2024-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-003 9884058 2029-06-26 U-4021 2024-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-003 9289472 2029-08-11 U-4021 2024-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-003 11045460 2029-08-19 U-4021 2024-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-004 9884058 2029-06-26 U-4021 2024-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-004 9289472 2029-08-11 U-4021 2024-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214927-004 11045460 2029-08-19 U-4021 2024-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214927-001 9884058 2029-06-26 U-4021 2024-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214927-001 9289472 2029-08-11 U-4021 2024-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214927-001 11045460 2029-08-19 U-4021 2024-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214927-002 9884058 2029-06-26 U-4021 2024-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214927-002 9289472 2029-08-11 U-4021 2024-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214927-002 11045460 2029-08-19 U-4021 2024-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214927-003 9884058 2029-06-26 U-4021 2024-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214927-003 9289472 2029-08-11 U-4021 2024-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214927-003 11045460 2029-08-19 U-4021 2024-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214927-004 9884058 2029-06-26 U-4021 2024-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214927-004 9289472 2029-08-11 U-4021 2024-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214927-004 11045460 2029-08-19 U-4021 2024-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214927-001 9884058 2029-06-26 U-4021 2024-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214927-001 9289472 2029-08-11 U-4021 2024-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214927-001 11045460 2029-08-19 U-4021 2024-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214927-002 9884058 2029-06-26 U-4021 2024-10-21 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 76 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MIPLYFFA ARIMOCLOMOL CITRATE Acer Therapeutics Inc. 5feffc0e-453d-47fa-91dd-38d4952309bc 2026-03-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 214927 application number: NDA214927
Documents# Document, Submission type, Date table Document Submission type Date 80001 ORIG 2024-10-28 79720 ORIG 2024-09-24 79662 ORIG 2024-09-20