FDA.reportPublic FDA data

Application 217858

Type
ANDA
Sponsor
CAPLIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 10MG BASE/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
A217858-001KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEEQ 10MG BASE/MLINJECTABLE / INJECTION2025-08-07

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
2026-02-19 14:30 UTC2026-02A217858-001KETAMINE HYDROCHLORIDEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2025-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217858-001KETAMINE HYDROCHLORIDEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2025-08-0731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217858-001KETAMINE HYDROCHLORIDEEQ 10MG BASE/MLINJECTABLE / INJECTION2025-08-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217858-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217858-001AP131067a03dcf5…

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 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEHenry Schein, Inc.dd8eff00-b92e-4f48-8b57-0464484d6ddf2026-07-30Warnings, Adverse reactionsName fallback
brand name: KETAMINE HYDROCHLORIDE
generic name: KETAMINE HYDROCHLORIDE
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEHospira, Inc.bb912318-2e22-4469-b0a2-774803ee1bb82026-05-12Warnings, Adverse reactionsName fallback
brand name: Ketamine Hydrochloride
generic name: KETAMINE HYDROCHLORIDE
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEGland Pharma Limitedb96a0a23-3ca0-4a92-bd8b-1e99219317722026-04-16Warnings, Adverse reactionsName fallback
brand name: Ketamine Hydrochloride
generic name: KETAMINE HYDROCHLORIDE
KetalarKETAMINE HYDROCHLORIDEPar Health USA, LLC14e8f864-8b8a-4e7e-8439-e510d31070632026-03-27Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE
KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEEugia US LLCf8b01c77-620d-4734-a771-b8524b65bcca2025-12-08Warnings, Adverse reactionsName fallback
brand name: KETAMINE HYDROCHLORIDE
generic name: KETAMINE HYDROCHLORIDE
ketamine hydrochlorideKETAMINE HYDROCHLORIDEFresenius Kabi USA, LLCac2e715d-251c-4e3f-b91c-972f466d0beb2025-10-03Warnings, Adverse reactionsName fallback
brand name: ketamine hydrochloride
generic name: KETAMINE HYDROCHLORIDE
KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEBaxter Healthcare Corporation549d6ed3-3c9b-4ea2-8aaf-f61d43e046022025-06-26Warnings, Adverse reactionsName fallback
brand name: KETAMINE HYDROCHLORIDE
generic name: KETAMINE HYDROCHLORIDE
ketamine hydrochlorideKETAMINE HYDROCHLORIDEFresenius Kabi USA, LLCcc67b0fd-ca73-49f6-b5ca-705dc73317762025-04-23Warnings, Adverse reactionsName fallback
brand name: ketamine hydrochloride
generic name: KETAMINE HYDROCHLORIDE
KETALARKETAMINE HYDROCHLORIDEHenry Schein, Inc46dab560-8ecd-4d92-8c92-6baa2310b09b2025-01-27Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE
Ketamine HydrochlorideKETAMINE HYDROCHLORIDECivica, Inc.58c86d9b-8694-4bd8-8254-f19ee3ad60b02024-02-26Warnings, Adverse reactionsName fallback
brand name: Ketamine Hydrochloride
generic name: KETAMINE HYDROCHLORIDE
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.58487c78-a641-4278-acc0-343596ee86832024-02-26Warnings, Adverse reactionsName fallback
brand name: Ketamine Hydrochloride
generic name: KETAMINE HYDROCHLORIDE
Ketamine HydrochlorideKETAMINE HYDROCHLORIDESagent Pharmaceuticals902c3785-a3cb-472b-ac15-394ac646271d2023-05-01Warnings, Adverse reactionsName fallback
brand name: Ketamine Hydrochloride
generic name: KETAMINE HYDROCHLORIDE
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCc8e90cec-621e-f8d8-e053-2a95a90a49d42023-04-27Warnings, Adverse reactionsName fallback
brand name: Ketamine Hydrochloride
generic name: KETAMINE HYDROCHLORIDE
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCea600f8a-857f-4e0e-e053-2995a90a017d2023-04-24Warnings, Adverse reactionsName fallback
brand name: Ketamine Hydrochloride
generic name: KETAMINE HYDROCHLORIDE