FDA.reportPublic FDA data

Application 218675

Type
ANDA
Sponsor
KNACK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)NoNo

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
A218675-001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTION2026-03-09

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 22:38:342026-08A218675-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTION2026-03-0984e616aacf4f…
2026-08-18 06:07:402026-07A218675-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTION2026-03-09caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218675-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTION2026-03-09a50c72e98297…

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexmedetomidine Hydrochloride in 0.9% Sodium ChlorideDEXMEDETOMIDINE HYDROCHLORIDESagent Pharmaceuticalsa99335d0-1e87-4180-bde3-cbb12bf91a522023-10-06Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEMedical Purchasing Solutions, LLCa268e759-9a3e-1d7b-e053-2a95a90a335b2023-06-01Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine Hydrochloride
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine hydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEMedical Purchasing Solutions, LLCa2666c50-3b55-1380-e053-2a95a90aea582023-06-01Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine hydrochloride
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEMedical Purchasing Solutions, LLC6937235f-ea25-4950-e053-2991aa0a9b742023-05-23Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine Hydrochloride
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEDr.Reddy's Laboratories Incd174c19d-56f1-4ef4-087c-23c26db8e40b2022-07-01Warnings, Adverse reactionsName fallback
brand name: DEXMEDETOMIDINE HYDROCHLORIDE
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDESun Pharmaceuticals Industries, Inc.4fe788bc-4ad1-4b32-83d3-dcbfcd8429aa2018-08-20Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine Hydrochloride
generic name: DEXMEDETOMIDINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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