FDA.reportPublic FDA data

Application 206263

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN CALCIUMPOWDER;INTRAVENOUSEQ 50MG BASE/VIALNoNo

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

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
A206263-001LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2016-06-16

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A206263-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2016-06-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206263-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2016-06-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206263-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2016-06-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206263-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2016-06-16a50c72e98297…

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 ZIP2022-06A206263-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206263-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206263-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206263-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206263-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206263-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206263-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A206263-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206263-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206263-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206263-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A206263-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206263-001AP1ea99ee380514…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206263-001AP1cb3db0bc1861…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevoleucovorinLEVOLEUCOVORINHikma Pharmaceuticals USA Inc.54f01988-aac2-4b0e-9d20-b7f621a0cd502021-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206263
application number: ANDA206263
ndc (product): 0143-9558

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9558LevoleucovorinLevoleucovorinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9558LevoleucovorinLevoleucovorinWest-Ward Pharmaceuticals CorpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19710ORIG2016-06-21