FDA.reportPublic FDA data

Application 220315

Type
ANDA
Sponsor
DR REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)NoNo
002DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220315-001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2026-02-25
A220315-002DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2026-02-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A220315-001AP
A220315-002AP

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220315-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2026-02-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220315-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2026-02-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220315-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220315-002AP1a50c72e98297…

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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexmedetomidineDEXMEDETOMIDINEEugia US LLC8c162541-986b-4b30-866c-b2631ba2c9752026-07-20Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine Hydrochloride
PrecedexDEXMEDETOMIDINE HYDROCHLORIDEHospira, Inc.92b7ddaa-e45a-4b64-a802-bb5df8771dd62026-06-17Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
PrecedexDEXMEDETOMIDINE HYDROCHLORIDEHospira, Inc.4419162d-81d4-49bd-96de-1729440bdb742026-06-09Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare Corporation7d057255-22a1-4b69-ad7c-7337fac8e9932026-05-29Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine Hydrochloride
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEAmneal Pharmaceuticals LLCeb1ba463-ab42-4f49-9ebe-3ad5af1083262026-05-28Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine Hydrochloride
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDECIVICA, INC.1faf1ac8-ff9b-4ed9-b562-06dab971173a2026-05-22Warnings, Adverse reactionsName fallback
brand name: DEXMEDETOMIDINE HYDROCHLORIDE
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
PRECEDEXDEXMEDETOMIDINE HYDROCHLORIDEHenry Schein, Inc.9eb336de-5fa5-4b46-b40b-a7ca5a0864bd2026-05-21Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEGland Pharma Limitedf307de7e-a9ab-4734-abb7-66b4e112bc512026-05-20Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine Hydrochloride
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
PrecedexDEXMEDETOMIDINE HYDROCHLORIDEHospira, Inc.548a88c0-afda-427e-75ac-5af0cfa2224c2026-05-20Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEMylan Institutional LLCf140de5a-f13d-46b4-a742-049c63e474f52026-05-20Warnings, Adverse reactionsName fallback
brand name: DEXMEDETOMIDINE HYDROCHLORIDE
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDEAmneal Pharmaceuticals LLC4df8cc35-fc80-4438-b982-9c4b7d17bad22026-05-19Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine Hydrochloride
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.ca67b379-f8b3-4d35-bf8a-235ecd4c42112026-03-04Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine Hydrochloride
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEFresenius Kabi USA, LLC1896a96e-25f8-494e-9a96-6463b52fb1022026-01-23Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine Hydrochloride
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare Company8ccb45a7-8290-469c-9644-a4dca967d88f2025-12-26Warnings, Adverse reactionsName fallback
brand name: DEXMEDETOMIDINE HYDROCHLORIDE
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare Company32242f34-6e2b-4098-bd8e-3d55162f31b52025-12-19Warnings, Adverse reactionsName fallback
brand name: DEXMEDETOMIDINE HYDROCHLORIDE
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Hydrochloride in Sodium ChlorideDEXMEDETOMIDINE HYDROCHLORIDEPrecision Dose, Inc.e9d5c989-ebf6-4377-9c6e-7aef848a03a12025-12-15Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEPiramal Critical Care Incc958aeb4-69ce-c3e2-e053-2a95a90a6d8d2025-09-25Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine Hydrochloride
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEFresenius Kabi USA, LLCc1b8eb58-596b-481d-beb6-ba9d2237abf42025-09-22Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine Hydrochloride
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDESagent Pharmaceuticals65885aef-faaf-4dec-a180-9a657f738bbc2025-06-26Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine Hydrochloride
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDESomerset Therapeutics, LLC649e777b-9b30-4f1e-9fb9-6bba575809762024-09-26Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine Hydrochloride
generic name: DEXMEDETOMIDINE HYDROCHLORIDE