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 44 .
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 2026-10-15 13:18:30 2026-09 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212102-001 FINTEPLA EQ 2.2MG BASE/ML SOLUTION / ORAL RLD, RS 2020-06-25 caaa826d4ba7…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 25 · 1,000 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N212102-001 10478441 2033-05-03 U-2860 2020-07-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 10478442 2033-05-03 U-2860 2020-07-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 12097206 2033-05-03 U-4013 2024-10-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 9549909 2033-05-03 U-2858 2020-07-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 9603814 2033-05-03 U-2858 2020-07-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 9603815 2033-05-03 U-2858 2020-07-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 9610260 2033-05-03 U-2858 2020-07-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 10478441*PED 2033-11-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 10478442*PED 2033-11-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 12097206*PED 2033-11-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 9549909*PED 2033-11-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 9603814*PED 2033-11-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 9603815*PED 2033-11-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 9610260*PED 2033-11-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 10947183 2036-12-20 Drug substance, Drug product 2021-04-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 10947183*PED 2037-06-20 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 10603290 2037-08-02 U-2861 2020-07-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 10603290 2037-08-02 U-3347 2020-07-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 11040018 2037-08-02 U-2861 2021-07-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 11040018 2037-08-02 U-3347 2021-07-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 11406606 2037-08-02 U-3406 2022-08-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 11406606 2037-08-02 U-3407 2022-08-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 11759440 2037-08-02 U-3694 2023-10-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 11786487 2037-08-02 U-3733 2023-11-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 10603290*PED 2038-02-02 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 11040018*PED 2038-02-02 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 11406606*PED 2038-02-02 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 11759440*PED 2038-02-02 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 11786487*PED 2038-02-02 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 10452815 2038-06-29 U-2859 Delist requested 2020-07-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212102-001 10452815*PED 2038-12-29 Pediatric extension c2088c7a36db…2026-09-14 22:38:34 2026-08 N212102-001 10478441 2033-05-03 U-2860 2020-07-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212102-001 10478442 2033-05-03 U-2860 2020-07-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212102-001 12097206 2033-05-03 U-4013 2024-10-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212102-001 9549909 2033-05-03 U-2858 2020-07-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212102-001 9603814 2033-05-03 U-2858 2020-07-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212102-001 9603815 2033-05-03 U-2858 2020-07-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212102-001 9610260 2033-05-03 U-2858 2020-07-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212102-001 10478441*PED 2033-11-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212102-001 10478442*PED 2033-11-03 Pediatric extension 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 212 observed states.
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 · 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