Home Applications 215487 Application 215487
Type NDA
Sponsor SCIENTURE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 REZENOPY NALOXONE HYDROCHLORIDE 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215487-001 REZENOPY NALOXONE HYDROCHLORIDE 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215487-001 12514854 2041-02-05 U-4397 2026-01-29 N215487-001 12622903 2041-02-05 Drug product 2026-06-03
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215487-001 NP 2027-04-19
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.
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 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD 2024-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD 2024-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 a50c72e98297…
Observed Orange Book patent history# 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 N215487-001 12514854 2041-02-05 U-4397 2026-01-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215487-001 12622903 2041-02-05 Drug product 2026-06-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215487-001 12514854 2041-02-05 U-4397 2026-01-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215487-001 12622903 2041-02-05 Drug product 2026-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215487-001 12514854 2041-02-05 U-4397 2026-01-29 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215487-001 12514854 2041-02-05 U-4397 2026-01-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215487-001 12622903 2041-02-05 Drug product 2026-06-03 a50c72e98297…
Observed Orange Book exclusivity history# 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.
Documents# Document, Submission type, Date table Document Submission type Date 85672 SUPPL 2026-04-10 85671 SUPPL 2026-04-10 79463 ORIG 2024-08-23 78193 ORIG 2024-04-22 78183 ORIG 2024-04-22