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 2 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEStrategic Sourcing Services LLC577fbd57-7054-4536-86c1-d43bc99cc7b12025-11-19WarningsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHenry Schein, Inc.ddeebc32-9aab-4a2f-8c87-74335d17d5ef2025-10-28Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEProPharma Distribution3f2bb95a-aeca-c0b7-e063-6394a90a627b2025-09-19Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.e6467385-6990-498c-8a0e-f4a40ef33cb72025-09-02Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEAMERISOURCE BERGENcce38c13-0d2f-49bb-94fa-6f2bbb4d59842025-08-31WarningsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst3ba53405-5e72-c035-e063-6294a90ac0b12025-08-05Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEFresenius Kabi USA, LLC201fdedf-1736-4e52-9d7d-de14292547fd2025-07-31Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEProPharma Distribution3856ea66-29b8-8fc2-e063-6394a90ac33a2025-07-18Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEEugia US LLC8bcf426a-b4fc-4f24-9ad0-fb26168a0b562025-05-14Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
naloxone hydrochlorideNALOXONE HYDROCHLORIDENorthStar RxLLCd4c44b74-4e36-4b63-80eb-64ce99ccb39f2025-01-27Warnings, Adverse reactionsName fallback
brand name: naloxone hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHenry Schein, Inc.d39635a4-ddb3-4d32-8211-eb84c78e9f592025-01-27Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9bcff682-1196-7cef-e053-2a95a90aa9542025-01-08Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEInternational Medication Systems, Limited236349ef-2cb5-47ca-a3a5-99534c3a49962024-12-16Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLC28f3e3bc-b1be-9f06-e063-6394a90a19362024-12-10Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAsclemed USA, Inc.7acf3bde-f858-4fbc-8a11-6741a3d27b8e2024-10-29WarningsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
naloxone hydrochlorideNALOXONE HYDROCHLORIDEBaxter Healthcare Corporation48137634-91d7-41e3-b54b-e4321d69668a2024-10-04Warnings, Adverse reactionsName fallback
brand name: naloxone hydrochloride
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEBryant Ranch Prepacked549649-dcbd-41f7-a774-876906751c5a2024-10-03WarningsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEEugia US LLCc7fa8d4f-28a7-4ef5-aef8-cbd4328ce5992024-07-06Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEEugia US LLC2725b9c0-5b1e-498b-9ec5-ee76a62e656a2024-07-06Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC1be2e38b-55ca-abea-e063-6394a90ac5482024-06-27WarningsName 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.