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 4 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NARCANNALOXONE HYDROCHLORIDEA-S Medication Solutions139c30b9-5600-48f5-8610-0cacd27823982023-09-28Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHospira, Inc.b598c237-032d-4bb5-0e92-50eabd863dac2023-06-04Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEA-S Medication Solutions3d2dcee4-7510-477b-95a8-9b2afb7739842023-05-23Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLC958577c3-d2c4-26ad-e053-2a95a90ad73a2023-05-15Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLC9e53f169-4a6e-6102-e053-2995a90ab3dc2023-05-09Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCada6856c-5293-fc2f-e053-2995a90a8ec62023-05-03Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCb621239f-0bbb-7d07-e053-2a95a90a287e2023-04-26Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALXONE HYDROCHLORIDEMedical Purchasing Solutions, LLC8959171f-eda6-158c-e053-2995a90a36b22023-04-26Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
naloxone hydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCfa1ca55b-f56b-0d9b-e053-6294a90a258a2023-04-24Warnings, Adverse reactionsName fallback
brand name: naloxone hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCea4ea2fe-af48-0b3c-e053-2a95a90a0ad52023-04-24Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCf9c5efca-443a-41a0-e053-6294a90a87742023-04-20Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC, DBA HealthFirst74fcd243-94b3-ec77-e053-2991aa0a229c2022-12-09Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEProficient Rx LP8d529b4c-85fd-4e50-9443-9080825307bf2022-10-01Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
NarcanNALOXONE HYDROCHLORIDEProficient Rx LP76b5a1ce-e601-457c-ab35-43533bba43942022-08-01Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride Injection, USP, Auto-InjectorNALOXONE HYDROCHLORIDEKaleo, Inc.b5463553-b775-47a3-8d10-31e01ca1ec722022-03-11Warnings, Adverse reactionsName fallback
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEInternational Medication Systems, Limitedd2f5bfa0-933e-46d0-8b1a-9f90e6aaba542021-12-13Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
naloxone hydrochlorideNALOXONE HYDROCHLORIDEBaxter Healthcare Corporationd04ae2d7-01b9-405d-bb7a-bf2d876ce26a2021-07-02Warnings, Adverse reactionsName fallback
brand name: naloxone hydrochloride
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMylan Institutional LLCd96ebf2e-1051-4b5b-b1c6-2543dbbb2d042021-04-21Warnings, Adverse reactionsName fallback
brand name: Naloxone Hydrochloride
generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEBaxter Healthcare Corporation3d8813be-6d22-46f1-ac25-0d8a817a521c2020-11-25Warnings, Adverse reactionsName fallback
brand name: NALOXONE HYDROCHLORIDE
generic name: NALOXONE HYDROCHLORIDE
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMylan Institutional LLCf0932877-1f3b-4d5e-82d2-dd6c53db47302020-08-17Warnings, 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.