Home Applications 212102 Application 212102
Type NDA
Sponsor ZOGENIX INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FINTEPLA FENFLUAMINE SOLUTION; ORAL 2.5MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N212102-001 FINTEPLA FENFLURAMINE HYDROCHLORIDE EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25
Orange Book patents# Current patent rows page 1 of 1 · 31 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 23 · 907 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 N212102-001 10478441 2033-05-03 U-2860 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10478442 2033-05-03 U-2860 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 12097206 2033-05-03 U-4013 2024-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9549909 2033-05-03 U-2858 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9603814 2033-05-03 U-2858 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9603815 2033-05-03 U-2858 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9610260 2033-05-03 U-2858 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10478441*PED 2033-11-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10478442*PED 2033-11-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 12097206*PED 2033-11-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9549909*PED 2033-11-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9603814*PED 2033-11-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9603815*PED 2033-11-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 9610260*PED 2033-11-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10947183 2036-12-20 Drug substance, Drug product 2021-04-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10947183*PED 2037-06-20 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10603290 2037-08-02 U-2861 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10603290 2037-08-02 U-3347 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11040018 2037-08-02 U-2861 2021-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11040018 2037-08-02 U-3347 2021-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11406606 2037-08-02 U-3406 2022-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11406606 2037-08-02 U-3407 2022-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11759440 2037-08-02 U-3694 2023-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11786487 2037-08-02 U-3733 2023-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10603290*PED 2038-02-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11040018*PED 2038-02-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11406606*PED 2038-02-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11759440*PED 2038-02-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 11786487*PED 2038-02-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10452815 2038-06-29 U-2859 Delist requested 2020-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212102-001 10452815*PED 2038-12-29 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 10478441 2033-05-03 U-2860 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 10478442 2033-05-03 U-2860 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 12097206 2033-05-03 U-4013 2024-10-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 9549909 2033-05-03 U-2858 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 9603814 2033-05-03 U-2858 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 9603815 2033-05-03 U-2858 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 9610260 2033-05-03 U-2858 2020-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 10478441*PED 2033-11-03 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212102-001 10478442*PED 2033-11-03 Pediatric extension 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 200 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 43376-322 FINTEPLA Fenfluramine Zogenix, Inc. NDA Current 43376-322 FINTEPLA Fenfluramine Zogenix, Inc. NDA Current 43376-322 FINTEPLA Fenfluramine Zogenix, Inc. NDA Current 43376-322 FINTEPLA Fenfluramine Zogenix, Inc. NDA Current 43376-322 FINTEPLA Fenfluramine Zogenix, Inc. NDA Current