Home Applications 202067 Application 202067
Type NDA
Sponsor LUNDBECK PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ONFI CLOBAZAM TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 002 ONFI CLOBAZAM TABLET;ORAL 10MG Yes No 003 ONFI CLOBAZAM TABLET;ORAL 20MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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/ RS Approval date N202067-001 ONFI CLOBAZAM 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 N202067-002 ONFI CLOBAZAM 10MG TABLET / ORAL AB RLD 2011-10-21 N202067-003 ONFI CLOBAZAM 20MG TABLET / ORAL AB RLD, RS 2011-10-21
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 · 126 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 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67386-314 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-314 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-314 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-314 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-314 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-314 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-314 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-314 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-315 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-315 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-315 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-315 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-315 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-315 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-315 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current 67386-315 Onfi clobazam Lundbeck Pharmaceuticals LLC NDA Current