FDA.reportPublic FDA data

Application 216719

Type
ANDA
Sponsor
PADAGIS ISRAEL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDESPRAY;NASAL8MG/SPRAYNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216719-001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE8MG/SPRAYSPRAY / NASAL2025-04-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A216719-001NALOXONE HYDROCHLORIDE8MG/SPRAYSPRAY / NASAL2025-04-2484e616aacf4f…
2026-08-18 06:07:402026-07A216719-001NALOXONE HYDROCHLORIDE8MG/SPRAYSPRAY / NASAL2025-04-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216719-001NALOXONE HYDROCHLORIDE8MG/SPRAYSPRAY / NASAL2025-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216719-001NALOXONE HYDROCHLORIDE8MG/SPRAYSPRAY / NASAL2025-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A216719-001NALOXONE HYDROCHLORIDE8MG/SPRAYSPRAY / NASAL2025-04-246a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216719-001NALOXONE HYDROCHLORIDE8MG/SPRAYSPRAY / NASAL2025-04-24a50c72e98297…

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 3 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst19b0603b-241f-f439-e063-6294a90ae85f2024-05-30WarningsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
REXTOVYNALOXONE HYDROCHLORIDEInternational Medication Systems, Ltd.fe9735db-c57e-44a8-bffb-b87a84c2a6f32024-05-15Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDECVS Pharmacy, Inc840e017d-0142-4d0e-a80e-327ac44bc0c52024-04-24WarningsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEWalgreen Co.3829826b-e48f-4e26-869f-6b9e4ee0a8402024-04-24WarningsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONEAmneal Pharmaceuticals NY LLC8779a073-dc6e-410a-9959-fd370f0079f92024-04-19WarningsName fallback
brand name: Naloxone Hydrochloride
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMylan Institutional LLC7faaedb3-227b-408d-b772-6b326638b00e2024-04-12Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEPar Health USA, LLC3ae08e26-223b-4971-b2f1-f1e183a3f9302024-04-11Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALXONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.1bef59b9-7d51-4f19-a054-44b8eb6c63982024-04-10Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
naloxone hydrochlorideNALOXONE HYDROCHLORIDELifestar Pharma LLCef647e2a-84e7-4e3e-942a-b6fc250141b62024-03-04Warnings, Adverse reactionsName fallback
brand name: naloxone hydrochloride
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc72a60fb-196d-3f02-e053-2995a90ad9062024-02-22Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst94ff1857-06da-7986-e053-2a95a90afb182024-02-19Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc90e2d85-ed94-2c00-e053-2a95a90ad2a02024-01-30Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEActavis Pharma, Inc.49350f7e-d613-40a8-8941-a2ec30eafdf32024-01-30WarningsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirste65e03c1-9a66-b30b-e053-2995a90aeb732024-01-27Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC, DBA HealthFirst74fc593e-ed47-efae-e053-2991aa0a59972024-01-25Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDETeva Pharmaceuticals, Inc.3a73ee4b-c2a4-496f-be90-9f78c80460622024-01-01WarningsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEA-S Medication Solutions46f27d04-d4d2-4ef1-9cc5-4d58f4056f062023-12-27WarningsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDESomerset Therapeutics, LLCb59ee3cc-9604-4abc-81be-897e2f42aa672023-12-19Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDE NASALA-S Medication Solutions4517afa1-4b17-4a15-b91b-65b18bd0558f2023-11-24Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEA-S Medication Solutions0b3b5214-6f91-4bba-82d6-d57b16845df52023-10-01Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.