FDA.reportPublic FDA data

Application 090359

Type
ANDA
Sponsor
BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEFENAMIC ACIDMEFENAMIC ACIDCAPSULE;ORAL250MGNoNo

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
A090359-001MEFENAMIC ACIDMEFENAMIC ACID250MGCAPSULE / ORAL2013-02-05

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 UTC2022-10A090359-001MEFENAMIC ACID250MGCAPSULE / ORAL2013-02-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090359-001MEFENAMIC ACID250MGCAPSULE / ORAL2013-02-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090359-001MEFENAMIC ACID250MGCAPSULE / ORAL2013-02-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090359-001MEFENAMIC ACID250MGCAPSULE / ORAL2013-02-05a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mefenamic AcidMEFENAMIC ACIDLupin Pharmaceuticals, Inc.d15733a9-d5fd-4d5f-86ce-e7ed8c706c7f2026-04-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mefenamic Acid
generic name: MEFENAMIC ACID
Mefenamic acidMEFENAMIC ACIDBryant Ranch Prepack9b8b3e03-4801-4ae8-b44e-e01d1ab1e34b2026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mefenamic acid
generic name: MEFENAMIC ACID
Mefenamic AcidMEFENAMIC ACIDMisemer Pharmaceuticals, Incd0291319-ab3e-20c8-e053-2a95a90afabb2026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mefenamic Acid
generic name: MEFENAMIC ACID
Mefenamic acidMEFENAMIC ACIDMicro Labs Limited4b0788cd-bdca-4fa5-9eba-01a270613aab2026-01-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mefenamic acid
generic name: MEFENAMIC ACID
Mefenamic AcidMEFENAMIC ACIDAdvanced Rx Pharmacy of Tennessee, LLCf8b1a4a2-83fc-6b4b-e053-6394a90ac46a2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mefenamic Acid
generic name: MEFENAMIC ACID
Mefenamic AcidMEFENAMIC ACIDAdvanced Rx of Tennessee, LLC1e927779-411a-b5f5-e063-6394a90aae932024-07-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mefenamic Acid
generic name: MEFENAMIC ACID

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51991-839Mefenamic AcidMefenamic AcidBreckenridge Pharmaceutical, Inc.ANDACurrent