Home Applications 208969 Application 208969
Type NDA
Sponsor AMPHASTAR PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 REXTOVY NALOXONE HYDROCHLORIDE SPRAY, METERED;NASAL 4MG/SPRAY Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N208969-001 REXTOVY NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208969-001 NP 2026-03-07
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 2026-08-18 06:07:40 2026-07 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD 2023-03-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD 2023-03-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD 2023-03-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD 2023-03-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208969-001 NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208969-001 NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 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 REXTOVY NALOXONE HYDROCHLORIDE International Medication Systems, Ltd. fe9735db-c57e-44a8-bffb-b87a84c2a6f3 2024-05-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 208969 application number: NDA208969
Documents# Document, Submission type, Date table Document Submission type Date 74681 SUPPL 2023-07-03 74667 SUPPL 2023-06-30 74007 ORIG 2023-04-17 73709 ORIG 2023-03-08 73708 ORIG 2023-03-08