FDA.reportPublic FDA data

Application 020259

Type
NDA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEPRONATOVAQUONETABLET;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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
N020259-001MEPRONATOVAQUONE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-11-25

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 · 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 UTC2022-10N020259-001MEPRON250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-11-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020259-001MEPRON250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-11-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020259-001MEPRON250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-11-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020259-001MEPRON250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-11-25a50c72e98297…

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 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atovaquone Oral SuspensionATOVAQUONEKVK-Tech, Inc.b31ff20a-c363-4be0-9bc0-3081c163b63c2026-06-16Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
ATOVAQUONEATOVAQUONEAvKARE54423fee-da60-25dc-e063-6294a90a25522026-06-14Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
AtovaquoneATOVAQUONECamber Pharmaceuticals, Inc.2445304e-4b4e-4358-b098-31f3c49c52ef2026-06-10Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
atovaquoneATOVAQUONEGlenmark Pharmaceuticals Inc., USA9045ba6f-938e-4717-bfa2-a3efe52f04cd2026-05-06Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
AtovaquoneATOVAQUONEPAI Holdings, LLC dba PAI Pharmadf6086d3-6100-422a-bf23-e9610027749b2026-04-30Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
ATOVAQUONEATOVAQUONEAmneal Pharmaceuticals LLCb7398fcf-522a-488a-8dd6-051561f628042026-04-29Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
MEPRONATOVAQUONEGlaxoSmithKline LLCb426b6bf-f07e-4580-97ae-dfca1ddf5b8f2026-03-20Warnings, Adverse reactionsName fallback
brand name: MEPRON
generic name: ATOVAQUONE
Atovaquone Oral SuspensionATOVAQUONEKesin Pharma Corporation4a2e2c4b-85aa-9b30-e063-6294a90a7bd92026-02-06Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
AtovaquoneATOVAQUONEGolden State Medical Supply, Inc.ddbfe1a9-df9b-79b0-e053-2995a90acc9b2025-12-17Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
AtovaquoneATOVAQUONEBionpharma Inc.bff4f4fc-6307-f414-e053-2a95a90ac0de2025-12-04Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
AtovaquoneATOVAQUONEChartwell Governmental & Specialty RX, LLC.e6770b85-54f8-4969-af02-7d81586be7612025-11-07Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
AtovaquoneATOVAQUONEAmerican Health Packaging1a8a43a2-bc26-4ee5-aa35-22a5477a71292025-10-17Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
ATOVAQUONEATOVAQUONEAvPAK4124ad97-f6b9-8afb-e063-6294a90ab9702025-10-14Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
AtovaquoneATOVAQUONEATLANTIC BIOLOGICALS CORP.40331de7-819e-5965-e063-6294a90ac91d2025-10-01Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
AtovaquoneATOVAQUONEKesin Pharma16b69156-e5de-c601-e063-6394a90afeae2025-09-15Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
AtovaquoneATOVAQUONEATLANTIC BIOLOGICALS CORP.f99a8a0c-2b42-4da0-8f5a-e963fc619e8b2025-05-12Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
AtovaquoneATOVAQUONEAbon Pharmaceuticals, LLC2d3715ed-6ddc-4c10-9d2c-9c80cb1dfd082025-05-12Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
AtovaquoneATOVAQUONELohxaba3cad0d-cce9-424f-ba5c-557dba8bef122025-03-20Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
AtovaquoneATOVAQUONEChartwell RX, LLCde0e29b5-a4c7-405c-a5b9-438729d9ba3a2024-05-24Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE
AtovaquoneATOVAQUONENorthStar RxLLCfc7bdd97-f780-4eed-80e0-72e70267b21a2024-04-12Warnings, Adverse reactionsName fallback
generic name: ATOVAQUONE

Reported adverse events (FAERS/openFDA)#

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