Application 071381

Type
ANDA
Sponsor
QUANTUM PHARMICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MECLODIUMMECLOFENAMATE SODIUMCAPSULE;ORALEQ 100MG BASENoNo

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
A071381-001MECLODIUMMECLOFENAMATE SODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-143f01610625f2…
2019-09-15 20:21 UTC2019-09A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071381-001MECLODIUMEQ 100MG BASECAPSULE / ORAL1987-07-14cb3db0bc1861…

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
Meclofenamate SodiumMECLOFENAMATE SODIUMMylan Pharmaceuticals Inc.96f19af4-de8f-4fd7-90d8-55fe6ebdd81d2026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MECLOFENAMATE SODIUM