Application 071949

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETAMINE HCLKETAMINE HYDROCHLORIDEInjectable; InjectionEQ 10MG BASE/MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEHenry Schein, Inc.76d6aad3-0515-49da-a6e1-3fe2a1938a242026-09-08Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE
Ketamine HydrochlorideKETAMINE HYDROCHLORIDECivica, Inc.58c86d9b-8694-4bd8-8254-f19ee3ad60b02026-06-09Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEHospira, Inc.bb912318-2e22-4469-b0a2-774803ee1bb82026-05-12Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEGland Pharma Limitedb96a0a23-3ca0-4a92-bd8b-1e99219317722026-04-16Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE
KetalarKETAMINE HYDROCHLORIDEPar Health USA, LLC14e8f864-8b8a-4e7e-8439-e510d31070632026-03-27Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE
ketamine hydrochlorideKETAMINE HYDROCHLORIDEFresenius Kabi USA, LLCac2e715d-251c-4e3f-b91c-972f466d0beb2025-10-03Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE
KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEBaxter Healthcare Corporation549d6ed3-3c9b-4ea2-8aaf-f61d43e046022025-06-26Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE
ketamine hydrochlorideKETAMINE HYDROCHLORIDEFresenius Kabi USA, LLCcc67b0fd-ca73-49f6-b5ca-705dc73317762025-04-23Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE
KETALARKETAMINE HYDROCHLORIDEHenry Schein, Inc46dab560-8ecd-4d92-8c92-6baa2310b09b2025-01-27Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.58487c78-a641-4278-acc0-343596ee86832024-02-26Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE
Ketamine HydrochlorideKETAMINE HYDROCHLORIDESagent Pharmaceuticals902c3785-a3cb-472b-ac15-394ac646271d2023-05-01Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCc8e90cec-621e-f8d8-e053-2a95a90a49d42023-04-27Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCea600f8a-857f-4e0e-e053-2995a90a017d2023-04-24Warnings, Adverse reactionsName fallback
generic name: KETAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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