FDA.reportPublic FDA data

Application 071083

Type
ANDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A071083-001NARCANNALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTION1988-07-28

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A071083-001NARCAN0.4MG/MLINJECTABLE / INJECTION1988-07-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071083-001NARCAN0.4MG/MLINJECTABLE / INJECTION1988-07-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071083-001NARCAN0.4MG/MLINJECTABLE / INJECTION1988-07-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A071083-001NARCAN0.4MG/MLINJECTABLE / INJECTION1988-07-28a50c72e98297…

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 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAmneal Pharmaceuticals LLC8091a73d-9ecd-4578-a57b-5d85a2c5a16a2026-08-25WarningsName fallback
generic name: NALOXONE HYDROCHLORIDE
NARCANNALOXONE HYDROCHLORIDE NASALEmergent Devices Inc.a0ebc83d-2892-40de-bc0a-775ce90b30db2026-08-17WarningsName fallback
brand name: NARCAN
Naloxone HydrochlorideNALOXONE HYDROCHLORIDESportpharm LLC3750bf77-342c-4469-8bbb-f71009aa03fa2026-07-02WarningsName fallback
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst53ed164c-dd09-4ea4-e063-6294a90a24342026-06-11Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEA-S Medication Solutions5906381c-81f4-4635-867a-e56e4d6296922026-06-03Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHospira, Inc.8535cc84-ad4a-4d67-8480-fb5a2e3406f82026-05-27Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDESomerset Therapeutics, LLCdfa48492-d83b-48cc-9ad1-bdc0c2ac99312026-05-05Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
NARCANNALOXONE HYDROCHLORIDE NASALSportpharm LLC3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f922026-04-24WarningsName fallback
brand name: NARCAN
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEBluePoint Laboratories327004b0-560a-84d0-e063-6294a90aa7432026-04-02WarningsName fallback
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC. DBA HealthFirst4d66b96a-acbb-2292-e063-6294a90af7882026-03-19Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHenry Schein, Incbd65e3fe-cd7a-4855-8f55-8cc3a0921ccc2026-03-02Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEREMEDYREPACK INC.68df290c-d776-4cfc-9565-332eb56c47232026-02-10Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
naloxone hydrochlorideNALOXONE HYDROCHLORIDELifestar Pharma LLCaef6719c-cd71-46ee-b7b1-1806b939bf3e2026-02-09Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAvKARE1766a7f1-d301-945f-e063-6294a90ac6f42026-01-14WarningsName fallback
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
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltdb5d40220-f194-4835-b70c-f304ecb222d52026-01-06WarningsName fallback
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEDr. Reddy's Laboratories, Inc.b1303f15-c48b-a44d-b28a-72f370094e022026-01-01Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEBPI Labs LLC5de44ee7-6525-4857-9a67-8882e96dbeb52025-12-26Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
NarcanNALOXONE HYDROCHLORIDEEmergent Devices Inc.724df050-5332-4d0a-9a5f-17bf08a547e12025-12-05Warnings, Adverse reactionsName fallback
brand name: Narcan
generic name: NALOXONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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