FDA.reportPublic FDA data

Application 089504

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMInjectable; InjectionEQ 5MG 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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leucovorin CalciumLEUCOVORIN CALCIUMAmerican Health Packagingf7004cbd-9827-466e-9683-adce4f13c6a62026-07-01Warnings, Adverse reactionsName fallback
brand name: Leucovorin Calcium
generic name: LEUCOVORIN CALCIUM
Leucovorin CalciumLEUCOVORIN CALCIUMSagent Pharmaceuticalsc0cbcbf6-6fd2-4cf3-877a-bb0fe3df4e592026-06-16Warnings, Adverse reactionsName fallback
brand name: Leucovorin Calcium
generic name: LEUCOVORIN CALCIUM
Leucovorin CalciumLEUCOVORIN CALCIUMTeva Pharmaceuticals USA, Inc.94669fc8-3c1c-4228-be27-09a1cd468c362026-03-31Warnings, Adverse reactionsName fallback
brand name: Leucovorin Calcium
generic name: LEUCOVORIN CALCIUM
Leucovorin CalciumLEUCOVORIN CALCIUMMajor Pharmaceuticals273407f5-0be2-435a-b7a8-f21be8ffbb3c2026-03-27Warnings, Adverse reactionsName fallback
brand name: Leucovorin Calcium
generic name: LEUCOVORIN CALCIUM
LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMLeading Pharma, LLCc8102043-79f2-421a-b849-94bac19007a62026-03-27Warnings, Adverse reactionsName fallback
brand name: LEUCOVORIN CALCIUM
generic name: LEUCOVORIN CALCIUM
Leucovorin CalciumLEUCOVORIN CALCIUMIngenus Pharmaceuticals, LLC7409cdee-9093-47af-a4c4-2c55ce1b63612026-03-18Warnings, Adverse reactionsName fallback
brand name: Leucovorin Calcium
generic name: LEUCOVORIN CALCIUM
VYKOURALEUCOVORIN CALCIUMAvyxa Pharma, LLCd122b875-435e-4e00-b945-7a0546df95c22026-03-12Warnings, Adverse reactionsName fallback
generic name: LEUCOVORIN CALCIUM
Leucovorin CalciumLEUCOVORIN CALCIUMSagent Pharmaceuticals9d0e5356-ff39-4a8e-944c-e808a21ef4b22026-03-11Warnings, Adverse reactionsName fallback
brand name: Leucovorin Calcium
generic name: LEUCOVORIN CALCIUM
Leucovorin CalciumLEUCOVORIN CALCIUMHikma Pharmaceuticals USA Inc.33663425-4731-4977-9127-9e59b6b914972026-03-10Warnings, Adverse reactionsName fallback
brand name: Leucovorin Calcium
generic name: LEUCOVORIN CALCIUM
Leucovorin CalciumLEUCOVORIN CALCIUMGLENMARK PHARMACEUTICALS INC., USA79d023ab-7d77-48c1-8f47-ea322fd58c2b2025-12-09Warnings, Adverse reactionsName fallback
brand name: Leucovorin Calcium
generic name: LEUCOVORIN CALCIUM
Leucovorin CalciumLEUCOVORIN CALCIUMGland Pharma Limited968b192b-72f3-41b0-a1f5-bab8a96d34192025-11-13Warnings, Adverse reactionsName fallback
brand name: Leucovorin Calcium
generic name: LEUCOVORIN CALCIUM
leucovorin calciumLEUCOVORIN CALCIUMBluePoint Laboratoriesf579879c-7d53-4663-8ad8-84b8b645cda52025-09-29Warnings, Adverse reactionsName fallback
brand name: leucovorin calcium
generic name: LEUCOVORIN CALCIUM
leucovorin calciumLEUCOVORIN CALCIUMMeitheal Pharmaceuticals Inc.9df20901-6980-4d4e-89ec-40f3c1f918522025-03-19Warnings, Adverse reactionsName fallback
brand name: leucovorin calcium
generic name: LEUCOVORIN CALCIUM
Leucovorin CalciumLEUCOVORIN CALCIUMSlate Run Pharmaceuticals, LLCd8bdd60c-9a1c-4ef4-ba6b-b911849128f12024-12-27Warnings, Adverse reactionsName fallback
brand name: Leucovorin Calcium
generic name: LEUCOVORIN CALCIUM
Leucovorin calciumLEUCOVORIN CALCIUMFresenius Kabi USA, LLC4b72d1fd-f389-45d9-b43b-510b45c922632024-10-14Warnings, Adverse reactionsName fallback
brand name: Leucovorin calcium
generic name: LEUCOVORIN CALCIUM
Leucovorin CalciumLEUCOVORIN CALCIUMFresenius Kabi USA, LLCab691d4e-e0d1-4ba1-9c7a-1cdcfcc3c17c2024-10-14Warnings, Adverse reactionsName fallback
brand name: Leucovorin Calcium
generic name: LEUCOVORIN CALCIUM
Leucovorin calciumLEUCOVORIN CALCIUMFresenius Kabi USA, LLCd5d4f0fd-7520-43a9-9acc-f7e117e1f6ee2024-10-14Warnings, Adverse reactionsName fallback
brand name: Leucovorin calcium
generic name: LEUCOVORIN CALCIUM
Leucovorin CalciumLEUCOVORIN CALCIUMEpic Pharma LLC2627a485-05b5-4dab-ac20-dc840e5c469d2023-11-08Warnings, Adverse reactionsName fallback
brand name: Leucovorin Calcium
generic name: LEUCOVORIN CALCIUM
Leucovorin CalciumLEUCOVORIN CALCIUMHikma Pharmaceuticals USA Inc.f198ab39-9394-4280-be44-93a88264a4502022-06-23Warnings, Adverse reactionsName fallback
brand name: Leucovorin Calcium
generic name: LEUCOVORIN CALCIUM
LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMMylan Institutional LLC1cb701ca-2478-4268-9d69-80293965d59d2022-06-01Warnings, Adverse reactionsName fallback
brand name: LEUCOVORIN CALCIUM
generic name: LEUCOVORIN CALCIUM

Reported adverse events (FAERS/openFDA)#

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