FDA.reportPublic FDA data

Application 210390

Type
ANDA
Sponsor
TORRENT PHARMS LLC

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 · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210390-001DIMETHYL FUMARATEDIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2025-01-06
A210390-002DIMETHYL FUMARATEDIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2025-01-06

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 UTC2026-02A210390-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2025-01-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210390-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2025-01-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210390-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2025-01-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210390-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2025-01-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210390-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2025-01-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210390-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2025-01-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210390-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORALAB2025-01-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210390-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORALAB2025-01-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210390-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORALAB2025-01-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210390-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORALAB2025-01-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210390-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORALAB2025-01-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210390-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORALAB2025-01-0603ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210390-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2025-01-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210390-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2025-01-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210390-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210390-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210390-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210390-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210390-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210390-002AB103ed91905a0d…

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 · 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
57986ORIG2019-03-13