Home Applications 217470 Application 217470
Type NDA
Sponsor INDIVIOR Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OPVEE NALMEFENE HYDROCHLORIDE SPRAY;NASAL EQ 2.7MG BASE/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 N217470-001 OPVEE NALMEFENE HYDROCHLORIDE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22
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 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 N217470-001 12290596 2042-08-04 U-4182 2025-05-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217470-001 NP 2026-05-22
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 2026-02-19 14:30 UTC 2026-02 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 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 2026-02-19 14:30 UTC 2026-02 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217470-001 12290596 2042-08-04 U-4182 2025-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217470-001 12290596 2042-08-04 U-4182 2025-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217470-001 12290596 2042-08-04 U-4182 2025-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217470-001 12290596 2042-08-04 U-4182 2025-05-20 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OPVEE NALMEFENE HYDROCHLORIDE Indivior Inc. 999a4269-9e54-4801-b2ac-2a7276f0b94f 2026-01-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 217470 application number: NDA217470
Documents# Document, Submission type, Date table Document Submission type Date 75024 ORIG 2023-08-10 74353 ORIG 2023-05-23 74347 ORIG 2023-05-22