FDA.reportPublic FDA data

Application 210291

Type
ANDA
Sponsor
SHILPA MEDICARE LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIMETHYL FUMARATEDIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORAL120MGNoNo
002DIMETHYL FUMARATEDIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORAL240MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dimethyl FumarateDIMETHYL FUMARATEGolden State Medical Supply, Inc.5361d5c6-c3eb-88e6-e063-6294a90ac08c2026-06-03Warnings, Adverse reactionsName fallback
brand name: Dimethyl Fumarate
generic name: DIMETHYL FUMARATE
dimethyl fumarateDIMETHYL FUMARATEGolden State Medical Supply, Inc.b8e5184d-5d1d-0a89-e053-2995a90a2d6d2026-04-15Warnings, Adverse reactionsName fallback
brand name: dimethyl fumarate
generic name: DIMETHYL FUMARATE
dimethyl fumarateDIMETHYL FUMARATEUpsher-Smith Laboratories, LLC48f56f42-2247-41a9-a1e9-07c3af50e5492026-01-19Warnings, Adverse reactionsName fallback
brand name: dimethyl fumarate
generic name: DIMETHYL FUMARATE
DIMETHYL FUMARATEDIMETHYL FUMARATEA-S Medication Solutionsc2b19329-5c1d-4879-85a9-36ffec3ff5cb2026-01-13Warnings, Adverse reactionsName fallback
brand name: DIMETHYL FUMARATE
generic name: DIMETHYL FUMARATE
Dimethyl FumarateDIMETHYL FUMARATESOLA Pharmaceuticals, LLCb4a200c1-f25a-4aa8-8770-06182fdeda9d2025-12-08Warnings, Adverse reactionsName fallback
brand name: Dimethyl Fumarate
generic name: DIMETHYL FUMARATE
DIMETHYL FUMARATEDIMETHYL FUMARATEQuallent Pharmaceuticals Health LLC39150ef0-ba48-4719-b7fd-9beb4d4ad3ce2025-10-30Warnings, Adverse reactionsName fallback
brand name: DIMETHYL FUMARATE
generic name: DIMETHYL FUMARATE
Dimethyl FumarateDIMETHYL FUMARATEDr. Reddy's Laboratories Inc.b00dcf89-59d3-9ab2-fd9b-16b9ec2d677b2025-10-10Warnings, Adverse reactionsName fallback
brand name: Dimethyl Fumarate
generic name: DIMETHYL FUMARATE
Dimethyl fumarateDIMETHYL FUMARATEAscend Laboratories, LLCe12d8fee-bd18-4f84-8333-c890f1d132b72025-09-26Warnings, Adverse reactionsName fallback
brand name: Dimethyl fumarate
generic name: DIMETHYL FUMARATE
Dimethyl FumarateDIMETHYL FUMARATEMacleods Pharmaceuticals Limitedf8ada3e3-55c0-43e3-95b9-c6d11ffc42dd2025-07-29Warnings, Adverse reactionsName fallback
brand name: Dimethyl Fumarate
generic name: DIMETHYL FUMARATE
Dimethyl fumarateDIMETHYL FUMARATECivicaScript LLCf3002b6a-841e-4247-9155-3acfb30cabcd2025-06-10Warnings, Adverse reactionsName fallback
brand name: Dimethyl fumarate
generic name: DIMETHYL FUMARATE
TECFIDERADIMETHYL FUMARATEBiogen Inc.665d7e74-036c-5f68-5b67-ab84b9b491512025-06-04Warnings, Adverse reactionsName fallback
generic name: DIMETHYL FUMARATE
Dimethyl FumarateDIMETHYL FUMARATEAmneal Pharmaceuticals NY LLC4c7626c6-2b1b-4865-818c-0c79c18c049d2025-05-30Warnings, Adverse reactionsName fallback
brand name: Dimethyl Fumarate
generic name: DIMETHYL FUMARATE
dimethyl fumarateDIMETHYL FUMARATEZydus Pharmaceuticals USA Inc.e7ef9b9e-d97a-4a56-b792-a1a2556131562025-04-01Warnings, Adverse reactionsName fallback
brand name: dimethyl fumarate
generic name: DIMETHYL FUMARATE
dimethyl fumarateDIMETHYL FUMARATEZydus Lifesciences Limited7203a262-de0f-42dd-b4fb-8856758b82e92025-04-01Name fallback
brand name: dimethyl fumarate
generic name: DIMETHYL FUMARATE
DIMETHYL FUMARATEDIMETHYL FUMARATESolco Healthcare US, LLCa3677dce-a44b-481f-8a76-9ff3a4d421052024-06-27Warnings, Adverse reactionsName fallback
brand name: DIMETHYL FUMARATE
generic name: DIMETHYL FUMARATE
DIMETHYL FUMARATEDIMETHYL FUMARATECamber Pharmaceuticals, Inc.b856ac70-71cd-477b-95b1-0a6132c260e82024-05-10Warnings, Adverse reactionsName fallback
brand name: DIMETHYL FUMARATE
generic name: DIMETHYL FUMARATE
DIMETHYL FUMARATEDIMETHYL-FUMARATEGlenmark Pharmaceuticals Inc., USAc3f65da9-f5f4-4161-aded-c23b16fd49ed2024-04-23Warnings, Adverse reactionsName fallback
brand name: DIMETHYL FUMARATE
Dimethyl FumarateDIMETHYL FUMARATEAurobindo Pharma Limited08f3a987-6571-42b3-854b-186d782b44942024-04-11Warnings, Adverse reactionsName fallback
brand name: Dimethyl Fumarate
generic name: DIMETHYL FUMARATE
DIMETHYL FUMARATEDIMETHYL FUMARATECipla USA Inc.6c42107a-2a42-4263-97b6-ae0d7675c92a2024-03-22Warnings, Adverse reactionsName fallback
brand name: DIMETHYL FUMARATE
generic name: DIMETHYL FUMARATE
Dimethyl FumarateDIMETHYL FUMARATEMSN LABORATORIES PRIVATE LIMITED074d2820-6cb4-437a-8f6f-a21cb0a8ee022021-07-13Warnings, Adverse reactionsName fallback
brand name: Dimethyl Fumarate
generic name: DIMETHYL FUMARATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56868ORIG2018-12-20