FDA.reportPublic FDA data

Application 040347

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEUCOVORIN CALCIUM PRESERVATIVE FREELEUCOVORIN CALCIUMINJECTABLE;INJECTIONEQ 10MG BASE/MLNoYes
002LEUCOVORIN CALCIUM PRESERVATIVE FREELEUCOVORIN CALCIUMSOLUTION;INTRAMUSCULAR, INTRAVENOUSEQ 500MG BASE/50ML (EQ 10MG BASE/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREELEUCOVORIN CALCIUMEQ 300MG BASE/30ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS2000-04-25
A040347-002LEUCOVORIN CALCIUM PRESERVATIVE FREELEUCOVORIN CALCIUMEQ 500MG BASE/50ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS2000-04-25

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.

Product history page 2 of 2 · 57 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-09-15 20:21 UTC2019-09A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAPRS2000-04-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAPRS2000-04-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTION2000-04-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTION2000-04-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTION2000-04-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTION2000-04-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTION2000-04-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTION2000-04-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTION2000-04-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAPRS2000-04-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAPRS2000-04-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAPRS2000-04-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAPRS2000-04-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAPRS2000-04-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAPRS2000-04-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040347-001LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 300MG BASE/30ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS2000-04-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040347-002LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 500MG BASE/50ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS2000-04-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040347-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040347-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040347-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040347-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040347-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040347-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040347-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A040347-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040347-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040347-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040347-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A040347-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040347-001AP1ea99ee380514…
2023-05-13 08:27 UTC2023-05A040347-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040347-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040347-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040347-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040347-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040347-001AP1cb3db0bc1861…

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

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
38887SUPPL2012-08-30
38886ORIG2004-06-08
42617ORIG2003-07-31
29935ORIG2000-04-25