FDA.reportPublic FDA data

Application 071682

Type
ANDA
Sponsor
SMITH AND NEPHEW

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEINJECTABLE;INJECTION0.4MG/MLNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071682-001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTION1987-11-17

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
2026-08-01 22:54:322026-06A071682-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTION1987-11-17a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naloxone HydrochlorideNALOXONE HYDROCHLORIDESportpharm LLC3750bf77-342c-4469-8bbb-f71009aa03fa2026-07-02WarningsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALXONE HYDROCHLORIDECivica, Inc.21d20dff-6efe-481e-a5a0-9c80ded73ca92026-06-30Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst53ed164c-dd09-4ea4-e063-6294a90a24342026-06-11Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEA-S Medication Solutions5906381c-81f4-4635-867a-e56e4d6296922026-06-03Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHospira, Inc.8535cc84-ad4a-4d67-8480-fb5a2e3406f82026-05-27Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDESomerset Therapeutics, LLCdfa48492-d83b-48cc-9ad1-bdc0c2ac99312026-05-05Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEBluePoint Laboratories327004b0-560a-84d0-e063-6294a90aa7432026-04-02WarningsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC. DBA HealthFirst4d66b96a-acbb-2292-e063-6294a90af7882026-03-19Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHenry Schein, Incbd65e3fe-cd7a-4855-8f55-8cc3a0921ccc2026-03-02Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEREMEDYREPACK INC.68df290c-d776-4cfc-9565-332eb56c47232026-02-10Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
naloxone hydrochlorideNALOXONE HYDROCHLORIDELifestar Pharma LLCaef6719c-cd71-46ee-b7b1-1806b939bf3e2026-02-09Warnings, Adverse reactionsName fallback
brand name: naloxone hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAvKARE1766a7f1-d301-945f-e063-6294a90ac6f42026-01-14WarningsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
RiViveNALOXONE HYDROCHLORIDEHarm Reduction Therapeutics, Inc.1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d2026-01-13WarningsName fallback
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDESina Health Inc2879294f-9af9-459e-e063-6394a90a08202026-01-12Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltdb5d40220-f194-4835-b70c-f304ecb222d52026-01-06WarningsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEBPI Labs LLC5de44ee7-6525-4857-9a67-8882e96dbeb52025-12-26Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAmneal Pharmaceuticals NY LLC8091a73d-9ecd-4578-a57b-5d85a2c5a16a2025-12-09WarningsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
NarcanNALOXONE HYDROCHLORIDEEmergent Devices Inc.724df050-5332-4d0a-9a5f-17bf08a547e12025-12-05Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
ZIMHINALOXONE HYDROCHLORIDEZMI Pharma Inc.523c0909-bff6-4010-988a-53de18b7cb3f2025-12-04Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEStrategic Sourcing Services LLC577fbd57-7054-4536-86c1-d43bc99cc7b12025-11-19WarningsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE