Home Applications 211635 Application 211635
Type NDA
Sponsor NEURELIS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VALTOCO DIAZEPAM SPRAY;NASAL 5MG/SPRAY Yes No 002 VALTOCO DIAZEPAM SPRAY;NASAL 7.5MG/SPRAY Yes No 003 VALTOCO DIAZEPAM SPRAY;NASAL 10MG/SPRAY Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N211635-001 VALTOCO DIAZEPAM 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 N211635-002 VALTOCO DIAZEPAM 7.5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 N211635-003 VALTOCO DIAZEPAM 10MG/SPRAY SPRAY / NASAL RLD, RS 2020-01-10
Orange Book patents# Current patent rows page 1 of 1 · 24 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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 3 · 117 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 2026-09-14 22:38:34 2026-08 N211635-001 VALTOCO 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-002 VALTOCO 7.5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-003 VALTOCO 10MG/SPRAY SPRAY / NASAL RLD, RS 2020-01-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211635-001 VALTOCO 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-002 VALTOCO 7.5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-003 VALTOCO 10MG/SPRAY SPRAY / NASAL RLD, RS 2020-01-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211635-001 VALTOCO 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211635-002 VALTOCO 7.5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211635-003 VALTOCO 10MG/SPRAY SPRAY / NASAL RLD, RS 2020-01-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211635-001 VALTOCO 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211635-002 VALTOCO 7.5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211635-003 VALTOCO 10MG/SPRAY SPRAY / NASAL RLD, RS 2020-01-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211635-001 VALTOCO 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211635-002 VALTOCO 7.5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211635-003 VALTOCO 10MG/SPRAY SPRAY / NASAL RLD, RS 2020-01-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211635-001 VALTOCO 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211635-002 VALTOCO 7.5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211635-003 VALTOCO 10MG/SPRAY SPRAY / NASAL RLD, RS 2020-01-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211635-001 VALTOCO 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211635-002 VALTOCO 7.5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211635-003 VALTOCO 10MG/SPRAY SPRAY / NASAL RLD, RS 2020-01-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211635-001 VALTOCO 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211635-002 VALTOCO 7.5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211635-003 VALTOCO 10MG/SPRAY SPRAY / NASAL RLD, RS 2020-01-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211635-001 VALTOCO 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211635-002 VALTOCO 7.5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211635-003 VALTOCO 10MG/SPRAY SPRAY / NASAL RLD, RS 2020-01-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211635-001 VALTOCO 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211635-002 VALTOCO 7.5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211635-003 VALTOCO 10MG/SPRAY SPRAY / NASAL RLD, RS 2020-01-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211635-001 VALTOCO 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211635-002 VALTOCO 7.5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211635-003 VALTOCO 10MG/SPRAY SPRAY / NASAL RLD, RS 2020-01-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211635-001 VALTOCO 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211635-002 VALTOCO 7.5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211635-003 VALTOCO 10MG/SPRAY SPRAY / NASAL RLD, RS 2020-01-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211635-001 VALTOCO 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211635-002 VALTOCO 7.5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211635-003 VALTOCO 10MG/SPRAY SPRAY / NASAL RLD, RS 2020-01-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211635-001 VALTOCO 5MG/SPRAY SPRAY / NASAL RLD 2020-01-10 301d65b070ca…
Observed Orange Book patent history# Patent history page 1 of 18 · 684 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N211635-001 11241414 2029-03-27 Drug product 2022-03-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-001 11793786 2029-03-27 Drug product 2023-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-001 12268664 2029-03-27 Drug product 2025-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-001 12521400 2029-03-27 Drug product 2026-01-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-001 8895546 2029-03-27 Drug product 2020-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-001 12337061 2032-06-13 U-4173 2025-06-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-001 12324852 2032-10-16 U-4173 2025-06-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-001 12599611 2042-06-10 U-4455 2026-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-002 11241414 2029-03-27 Drug product 2022-03-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-002 11793786 2029-03-27 Drug product 2023-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-002 12268664 2029-03-27 Drug product 2025-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-002 12521400 2029-03-27 Drug product 2026-01-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-002 8895546 2029-03-27 Drug product 2020-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-002 12337061 2032-06-13 U-4173 2025-06-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-002 12324852 2032-10-16 U-4173 2025-06-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-002 12599611 2042-06-10 U-4455 2026-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-003 11241414 2029-03-27 Drug product 2022-03-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-003 11793786 2029-03-27 Drug product 2023-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-003 12268664 2029-03-27 Drug product 2025-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-003 12521400 2029-03-27 Drug product 2026-01-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-003 8895546 2029-03-27 Drug product 2020-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-003 12337061 2032-06-13 U-4173 2025-06-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-003 12324852 2032-10-16 U-4173 2025-06-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211635-003 12599611 2042-06-10 U-4455 2026-04-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211635-001 11241414 2029-03-27 Drug product 2022-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-001 11793786 2029-03-27 Drug product 2023-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-001 12268664 2029-03-27 Drug product 2025-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-001 12521400 2029-03-27 Drug product 2026-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-001 8895546 2029-03-27 Drug product 2020-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-001 12337061 2032-06-13 U-4173 2025-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-001 12324852 2032-10-16 U-4173 2025-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-001 12599611 2042-06-10 U-4455 2026-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-002 11241414 2029-03-27 Drug product 2022-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-002 11793786 2029-03-27 Drug product 2023-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-002 12268664 2029-03-27 Drug product 2025-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-002 12521400 2029-03-27 Drug product 2026-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-002 8895546 2029-03-27 Drug product 2020-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-002 12337061 2032-06-13 U-4173 2025-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-002 12324852 2032-10-16 U-4173 2025-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211635-002 12599611 2042-06-10 U-4455 2026-04-20 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 195 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 72252-505 Valtoco diazepam Neurelis, Inc NDA Current 72252-505 Valtoco diazepam Neurelis, Inc NDA Current 72252-505 Valtoco diazepam Neurelis, Inc NDA Current 72252-505 Valtoco diazepam Neurelis, Inc NDA Current 72252-510 Valtoco diazepam Neurelis, Inc NDA Current 72252-510 Valtoco diazepam Neurelis, Inc NDA Current 72252-510 Valtoco diazepam Neurelis, Inc NDA Current 72252-510 Valtoco diazepam Neurelis, Inc NDA Current 72252-515 Valtoco diazepam Neurelis, Inc NDA Current 72252-515 Valtoco diazepam Neurelis, Inc NDA Current 72252-515 Valtoco diazepam Neurelis, Inc NDA Current 72252-515 Valtoco diazepam Neurelis, Inc NDA Current 72252-520 Valtoco diazepam Neurelis, Inc NDA Current 72252-520 Valtoco diazepam Neurelis, Inc NDA Current 72252-520 Valtoco diazepam Neurelis, Inc NDA Current 72252-520 Valtoco diazepam Neurelis, Inc NDA Current