Home Applications 020789 Application 020789
Type NDA
Sponsor SUNOVION PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZONEGRAN ZONISAMIDE CAPSULE;ORAL 100MG Yes Yes 002 ZONEGRAN ZONISAMIDE CAPSULE;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 003 ZONEGRAN ZONISAMIDE CAPSULE;ORAL 25MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020789-001 ZONEGRAN ZONISAMIDE 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 N020789-002 ZONEGRAN ZONISAMIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 N020789-003 ZONEGRAN ZONISAMIDE 25MG CAPSULE / ORAL AB RLD 2003-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
Product history page 1 of 4 · 123 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 2026-02-19 14:30 UTC 2026-02 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59212-680 Zonegran Zonisamide Concordia Pharmaceuticals Inc. NDA Current 59212-680 Zonegran zonisamide Concordia Pharmaceuticals Inc. NDA Current 59212-680 Zonegran Zonisamide Concordia Pharmaceuticals Inc. NDA Current 59212-680 Zonegran Zonisamide Concordia Pharmaceuticals Inc. NDA Current 59212-681 Zonegran Zonisamide Concordia Pharmaceuticals Inc. NDA Current 59212-681 Zonegran zonisamide Concordia Pharmaceuticals Inc. NDA Current 59212-681 Zonegran Zonisamide Concordia Pharmaceuticals Inc. NDA Current 59212-681 Zonegran Zonisamide Concordia Pharmaceuticals Inc. NDA Current