Home Applications 211321 Application 211321
Type NDA
Sponsor UCB INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NAYZILAM MIDAZOLAM SPRAY;NASAL 5MG/SPRAY Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N211321-001 NAYZILAM MIDAZOLAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211321-001 ODE-243 2026-05-17
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 · 41 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 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 164 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 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 d06236e962d9…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 59 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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50474-500 Nayzilam midazolam UCB, Inc. NDA Current 50474-500 Nayzilam midazolam UCB, Inc. NDA Current 50474-500 Nayzilam midazolam UCB, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 73204 SUPPL 2023-01-17 73203 SUPPL 2023-01-17 73186 SUPPL 2023-01-17 66155 SUPPL 2021-02-09 66154 SUPPL 2021-02-09 66142 SUPPL 2021-02-09 62096 ORIG 2020-03-10 59137 ORIG 2019-06-20 58764 ORIG 2019-05-17 58763 ORIG 2019-05-17