Home Applications 208078 Application 208078
Type NDA
Sponsor CATALYST PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FIRDAPSE AMIFAMPRIDINE PHOSPHATE TABLET;ORAL EQ 10MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N208078-001 FIRDAPSE AMIFAMPRIDINE PHOSPHATE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208078-001 11060128 2032-06-29 U-2956 2021-07-19 N208078-001 11268128 2032-06-29 U-2956 2022-03-10 N208078-001 11274331 2032-06-29 U-2956 2022-03-30 N208078-001 11274332 2032-06-29 U-2956 2022-03-30 N208078-001 10793893 2034-05-26 U-2956 2020-10-07 N208078-001 10626088 2037-02-25 Drug product 2022-08-09
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208078-001 ODE-553 2029-09-29
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208078-001 FIRDAPSE EQ 10MG BASE TABLET / ORAL RLD, RS 2018-11-28 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 5 · 193 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N208078-001 11060128 2032-06-29 U-2956 2021-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208078-001 11268128 2032-06-29 U-2956 2022-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208078-001 11274331 2032-06-29 U-2956 2022-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208078-001 11274332 2032-06-29 U-2956 2022-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208078-001 10793893 2034-05-26 U-2956 2020-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208078-001 10626088 2037-02-25 Drug product 2022-08-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208078-001 11060128 2032-06-29 U-2956 2021-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208078-001 11268128 2032-06-29 U-2956 2022-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208078-001 11274331 2032-06-29 U-2956 2022-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208078-001 11274332 2032-06-29 U-2956 2022-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208078-001 10793893 2034-05-26 U-2956 2020-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208078-001 10626088 2037-02-25 Drug product 2022-08-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208078-001 11060128 2032-06-29 U-2956 2021-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208078-001 11268128 2032-06-29 U-2956 2022-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208078-001 11274331 2032-06-29 U-2956 2022-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208078-001 11274332 2032-06-29 U-2956 2022-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208078-001 10793893 2034-05-26 U-2956 2020-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208078-001 10626088 2037-02-25 Drug product 2022-08-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208078-001 11060128 2032-06-29 U-2956 2021-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208078-001 11268128 2032-06-29 U-2956 2022-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208078-001 11274331 2032-06-29 U-2956 2022-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208078-001 11274332 2032-06-29 U-2956 2022-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208078-001 10793893 2034-05-26 U-2956 2020-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208078-001 10626088 2037-02-25 Drug product 2022-08-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208078-001 11060128 2032-06-29 U-2956 2021-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208078-001 11268128 2032-06-29 U-2956 2022-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208078-001 11274331 2032-06-29 U-2956 2022-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208078-001 11274332 2032-06-29 U-2956 2022-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208078-001 10793893 2034-05-26 U-2956 2020-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208078-001 10626088 2037-02-25 Drug product 2022-08-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208078-001 11060128 2032-06-29 U-2956 2021-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208078-001 11268128 2032-06-29 U-2956 2022-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208078-001 11274331 2032-06-29 U-2956 2022-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208078-001 11274332 2032-06-29 U-2956 2022-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208078-001 10793893 2034-05-26 U-2956 2020-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208078-001 10626088 2037-02-25 Drug product 2022-08-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208078-001 11060128 2032-06-29 U-2956 2021-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208078-001 11268128 2032-06-29 U-2956 2022-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208078-001 11274331 2032-06-29 U-2956 2022-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208078-001 11274332 2032-06-29 U-2956 2022-03-30 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 87 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 Firdapse AMIFAMPRIDINE PHOSPHATE Catalyst Pharmaceuticals, Inc. f015fe60-3128-4a43-8c31-19fc6b5def3f 2026-04-16 Warnings, Adverse reactions Exact identifier application applno (NDA): 208078 application number: NDA208078 ndc (product): 69616-211
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 69616-211 Firdapse amifampridine phosphate Catalyst Pharmaceuticals, Inc. NDA Current 69616-211 Firdapse amifampridine phosphate Catalyst Pharmaceuticals, Inc. NDA Current 69616-211 Firdapse amifampridine phosphate Catalyst Pharmaceuticals, Inc. NDA Current 69616-211 Firdapse amifampridine phosphate Catalyst Pharmaceuticals, Inc. NDA Current 69616-211 Firdapse amifampridine phosphate Catalyst Pharmaceuticals, Inc. NDA Current