FDA.reportPublic FDA data

Application 081278

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMINJECTABLE;INJECTIONEQ 50MG BASE/VIALNoNo

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
A081278-001LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMEQ 50MG BASE/VIALINJECTABLE / INJECTION1993-09-28

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
2026-08-01 22:54:322026-06A081278-001LEUCOVORIN CALCIUMEQ 50MG BASE/VIALINJECTABLE / INJECTION1993-09-28a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 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 CALCIUMLeading Pharma, LLCc8102043-79f2-421a-b849-94bac19007a62023-09-11Warnings, 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