FDA.reportPublic FDA data

Application 211003

Type
ANDA
Sponsor
MEITHEAL

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 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
A211003-001LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-22

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
2026-02-19 14:30 UTC2026-02A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-223f01610625f2…
2019-09-15 20:21 UTC2019-09A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-22b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUSAP2019-08-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211003-001LEVOLEUCOVORIN CALCIUMEQ 50MG BASE/VIALPOWDER / INTRAVENOUS2019-08-22a50c72e98297…

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 ZIP2022-06A211003-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211003-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211003-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211003-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211003-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211003-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211003-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A211003-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211003-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211003-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211003-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A211003-001AP1b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211003-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211003-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211003-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211003-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211003-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211003-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211003-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211003-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211003-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211003-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211003-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211003-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211003-001AP1cb3db0bc1861…

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
LevoleucovorinLEVOLEUCOVORIN CALCIUMMeitheal Pharmaceuticals Incb4dd0e14-d42a-4581-b1f0-7ba95b50bca62022-12-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211003
application number: ANDA211003
ndc (product): 71288-104

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71288-104Levoleucovorinlevoleucovorin calciumMeitheal Pharmaceuticals IncANDACurrent
71288-104Levoleucovorinlevoleucovorin calciumMeitheal Pharmaceuticals IncANDACurrent
71288-104Levoleucovorinlevoleucovorin calciumMeitheal Pharmaceuticals IncANDACurrent
71288-104Levoleucovorinlevoleucovorin calciumMeitheal Pharmaceuticals IncANDACurrent