Home Applications 210833 Application 210833
Type NDA
Sponsor AQUESTIVE THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SYMPAZAN CLOBAZAM FILM;ORAL 5MG Yes No 002 SYMPAZAN CLOBAZAM FILM;ORAL 10MG Yes No 003 SYMPAZAN CLOBAZAM FILM;ORAL 20MG Yes Yes
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 N210833-001 SYMPAZAN CLOBAZAM 5MG FILM / ORAL RLD 2018-11-01 N210833-002 SYMPAZAN CLOBAZAM 10MG FILM / ORAL RLD 2018-11-01 N210833-003 SYMPAZAN CLOBAZAM 20MG FILM / ORAL RLD, RS 2018-11-01
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210833-001 12290597 2039-09-05 U-724 Drug product 2025-11-12 N210833-001 12403090 2039-09-05 U-724 Drug product 2025-11-12 N210833-001 11541002 2040-01-31 U-724 Drug product 2023-01-04 N210833-002 12290597 2039-09-05 U-724 Drug product 2025-11-12 N210833-002 12403090 2039-09-05 U-724 Drug product 2025-11-12 N210833-002 11541002 2040-01-31 U-724 Drug product 2023-01-04 N210833-003 11541002 2040-01-31 U-724 Drug product 2023-01-04
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 N210833-001 SYMPAZAN 5MG FILM / ORAL RLD 2018-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210833-002 SYMPAZAN 10MG FILM / ORAL RLD 2018-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210833-003 SYMPAZAN 20MG FILM / ORAL RLD, RS 2018-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210833-001 SYMPAZAN 5MG FILM / ORAL RLD 2018-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210833-002 SYMPAZAN 10MG FILM / ORAL RLD 2018-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210833-003 SYMPAZAN 20MG FILM / ORAL RLD, RS 2018-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210833-001 SYMPAZAN 5MG FILM / ORAL RLD 2018-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210833-002 SYMPAZAN 10MG FILM / ORAL RLD 2018-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210833-003 SYMPAZAN 20MG FILM / ORAL RLD, RS 2018-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210833-001 SYMPAZAN 5MG FILM / ORAL RLD 2018-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210833-002 SYMPAZAN 10MG FILM / ORAL RLD 2018-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210833-003 SYMPAZAN 20MG FILM / ORAL RLD, RS 2018-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210833-001 SYMPAZAN 5MG FILM / ORAL RLD 2018-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210833-002 SYMPAZAN 10MG FILM / ORAL RLD 2018-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210833-003 SYMPAZAN 20MG FILM / ORAL RLD, RS 2018-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210833-001 SYMPAZAN 5MG FILM / ORAL RLD 2018-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210833-002 SYMPAZAN 10MG FILM / ORAL RLD 2018-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210833-003 SYMPAZAN 20MG FILM / ORAL RLD, RS 2018-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210833-001 SYMPAZAN 5MG FILM / ORAL RLD 2018-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210833-002 SYMPAZAN 10MG FILM / ORAL RLD 2018-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210833-003 SYMPAZAN 20MG FILM / ORAL RLD, RS 2018-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210833-001 SYMPAZAN 5MG FILM / ORAL RLD 2018-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210833-002 SYMPAZAN 10MG FILM / ORAL RLD 2018-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210833-003 SYMPAZAN 20MG FILM / ORAL RLD, RS 2018-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210833-001 SYMPAZAN 5MG FILM / ORAL RLD 2018-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210833-002 SYMPAZAN 10MG FILM / ORAL RLD 2018-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210833-003 SYMPAZAN 20MG FILM / ORAL RLD, RS 2018-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210833-001 SYMPAZAN 5MG FILM / ORAL RLD 2018-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210833-002 SYMPAZAN 10MG FILM / ORAL RLD 2018-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210833-003 SYMPAZAN 20MG FILM / ORAL RLD, RS 2018-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210833-001 SYMPAZAN 5MG FILM / ORAL RLD 2018-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210833-002 SYMPAZAN 10MG FILM / ORAL RLD 2018-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210833-003 SYMPAZAN 20MG FILM / ORAL RLD, RS 2018-11-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210833-001 SYMPAZAN 5MG FILM / ORAL RLD 2018-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210833-002 SYMPAZAN 10MG FILM / ORAL RLD 2018-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210833-003 SYMPAZAN 20MG FILM / ORAL RLD, RS 2018-11-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210833-001 SYMPAZAN 5MG FILM / ORAL RLD 2018-11-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210833-002 SYMPAZAN 10MG FILM / ORAL RLD 2018-11-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210833-003 SYMPAZAN 20MG FILM / ORAL RLD, RS 2018-11-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210833-001 SYMPAZAN 5MG FILM / ORAL RLD 2018-11-01 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 8 · 294 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 N210833-001 12290597 2039-09-05 U-724 Drug product 2025-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210833-001 12403090 2039-09-05 U-724 Drug product 2025-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210833-001 11541002 2040-01-31 U-724 Drug product 2023-01-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210833-002 12290597 2039-09-05 U-724 Drug product 2025-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210833-002 12403090 2039-09-05 U-724 Drug product 2025-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210833-002 11541002 2040-01-31 U-724 Drug product 2023-01-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210833-003 11541002 2040-01-31 U-724 Drug product 2023-01-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210833-001 12290597 2039-09-05 U-724 Drug product 2025-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210833-001 12403090 2039-09-05 U-724 Drug product 2025-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210833-001 11541002 2040-01-31 U-724 Drug product 2023-01-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210833-002 12290597 2039-09-05 U-724 Drug product 2025-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210833-002 12403090 2039-09-05 U-724 Drug product 2025-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210833-002 11541002 2040-01-31 U-724 Drug product 2023-01-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210833-003 11541002 2040-01-31 U-724 Drug product 2023-01-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210833-001 11541002 2040-01-31 U-724 Drug product 2023-01-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210833-002 11541002 2040-01-31 U-724 Drug product 2023-01-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210833-003 11541002 2040-01-31 U-724 Drug product 2023-01-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210833-001 11541002 2040-01-31 U-724 Drug product 2023-01-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210833-002 11541002 2040-01-31 U-724 Drug product 2023-01-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210833-003 11541002 2040-01-31 U-724 Drug product 2023-01-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210833-001 11541002 2040-01-31 U-724 Drug product 2023-01-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210833-002 11541002 2040-01-31 U-724 Drug product 2023-01-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210833-003 11541002 2040-01-31 U-724 Drug product 2023-01-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210833-001 8765167 2024-02-20 Drug product 2018-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210833-001 8603514 2024-04-03 Drug product 2018-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210833-001 11541002 2040-01-31 U-724 Drug product 2023-01-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210833-002 8765167 2024-02-20 Drug product 2018-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210833-002 8603514 2024-04-03 Drug product 2018-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210833-002 11541002 2040-01-31 U-724 Drug product 2023-01-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210833-003 8765167 2024-02-20 Drug product 2018-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210833-003 8603514 2024-04-03 Drug product 2018-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210833-003 11541002 2040-01-31 U-724 Drug product 2023-01-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210833-001 8765167 2024-02-20 Drug product 2018-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210833-001 8603514 2024-04-03 Drug product 2018-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210833-001 11541002 2040-01-31 U-724 Drug product 2023-01-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210833-002 8765167 2024-02-20 Drug product 2018-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210833-002 8603514 2024-04-03 Drug product 2018-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210833-002 11541002 2040-01-31 U-724 Drug product 2023-01-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210833-003 8765167 2024-02-20 Drug product 2018-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210833-003 8603514 2024-04-03 Drug product 2018-11-30 2680178bc6a6…
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 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10094-205 SYMPAZAN clobazam Aquestive Therapeutics NDA Current 10094-205 SYMPAZAN clobazam Aquestive Therapeutics NDA Current 10094-205 SYMPAZAN clobazam Aquestive Therapeutics NDA Current 10094-205 SYMPAZAN clobazam Aquestive Therapeutics NDA Current 10094-205 SYMPAZAN clobazam Aquestive Therapeutics NDA Current 10094-210 SYMPAZAN clobazam Aquestive Therapeutics NDA Current 10094-210 SYMPAZAN clobazam Aquestive Therapeutics NDA Current 10094-210 SYMPAZAN clobazam Aquestive Therapeutics NDA Current 10094-210 SYMPAZAN clobazam Aquestive Therapeutics NDA Current 10094-210 SYMPAZAN clobazam Aquestive Therapeutics NDA Current 10094-220 SYMPAZAN clobazam Aquestive Therapeutics NDA Current 10094-220 SYMPAZAN clobazam Aquestive Therapeutics NDA Current 10094-220 SYMPAZAN clobazam Aquestive Therapeutics NDA Current 10094-220 SYMPAZAN clobazam Aquestive Therapeutics NDA Current 10094-220 SYMPAZAN clobazam Aquestive Therapeutics NDA Current