FDA.reportPublic FDA data

Application 207971

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FINGOLIMODFINGOLIMODCAPSULE;ORAL0.5MGNoNo

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
A207971-001FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORAL2020-06-29

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
2026-08-01 22:54:322026-06A207971-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORAL2020-06-29a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FINGOLIMODFINGOLIMODQuallent Pharmaceuticals Health LLC5434bd4a-2610-0e17-4f14-513ff1cbb8222026-06-10Warnings, Adverse reactionsName fallback
brand name: FINGOLIMOD
generic name: FINGOLIMOD
FingolimodFINGOLIMODCivicaScript LLCe1960f9b-f739-452c-b167-245551bf36902026-05-25Warnings, Adverse reactionsName fallback
brand name: Fingolimod
generic name: FINGOLIMOD
FingolimodFINGOLIMODAlembic Pharmaceuticals Limitedd0538769-3cec-4cf2-97e5-41e79599c1812026-04-30Warnings, Adverse reactionsName fallback
brand name: Fingolimod
generic name: FINGOLIMOD
FingolimodFINGOLIMODAlembic Pharmaceuticals Inc.54bf842e-9772-424d-87b2-61863b6f4b192026-04-27Warnings, Adverse reactionsName fallback
brand name: Fingolimod
generic name: FINGOLIMOD
FingolimodFINGOLIMOD HYDROCHLORIDEAscend Laboratories, LLC0f638feb-6986-41e4-8f9c-2e6b84a5bb442026-03-27Warnings, Adverse reactionsName fallback
brand name: Fingolimod
fingolimodFINGOLIMODGlenmark Pharmaceuticals Inc., USA8fe14efd-8f61-40db-9069-bb17daf3261a2026-01-31Warnings, Adverse reactionsName fallback
brand name: fingolimod
generic name: FINGOLIMOD
FingolimodFINGOLIMODAvKARE1171df44-48b4-6ef2-e063-6294a90aa1212026-01-13Warnings, Adverse reactionsName fallback
brand name: Fingolimod
generic name: FINGOLIMOD
FINGOLIMODFINGOLIMODAurobindo Pharma Limitedd6301307-55c6-4b91-a505-ff93c865f8592026-01-01Warnings, Adverse reactionsName fallback
brand name: FINGOLIMOD
generic name: FINGOLIMOD
FingolimodFINGOLIMODCamber Pharmaceuticals, Inc.c3199508-3d6a-4e44-96f0-bbde9969edcb2025-12-18Warnings, Adverse reactionsName fallback
brand name: Fingolimod
generic name: FINGOLIMOD
FINGOLIMODFINGOLIMODBiocon Pharma Inc.550a5fa3-94a4-0b55-9cb5-c0178acfe3192025-11-26Warnings, Adverse reactionsName fallback
brand name: FINGOLIMOD
generic name: FINGOLIMOD
FingolimodFINGOLIMODTeva Pharmaceuticals, Inc.d9aa1078-fd72-47ef-84b2-2e1ad17b12a22025-11-01Warnings, Adverse reactionsName fallback
brand name: Fingolimod
generic name: FINGOLIMOD
FingolimodFINGOLIMODDr. Reddy's Laboratories Inc56badc2a-6747-9284-300e-bf072eb072ed2025-10-22Warnings, Adverse reactionsName fallback
brand name: Fingolimod
generic name: FINGOLIMOD
FingolimodFINGOLIMODApotex Corp.a545c6fc-7006-52c2-f476-34e9801ac04f2025-09-11Warnings, Adverse reactionsName fallback
brand name: Fingolimod
generic name: FINGOLIMOD
FingolimodFINGOLIMODSun Pharmaceutical Industries, Inc.b228dac8-b07d-424d-b23b-a03573517c542025-09-05Warnings, Adverse reactionsName fallback
brand name: Fingolimod
generic name: FINGOLIMOD
FingolimodFINGOLIMODZydus Pharmaceuticals USA Inc.e738dbd9-f4cc-49a0-98ce-73dd0c3ff3b32025-09-02Warnings, Adverse reactionsName fallback
brand name: Fingolimod
generic name: FINGOLIMOD
FingolimodFINGOLIMODZydus Lifesciences Limited5a0319b4-4bc6-4564-9687-9cfd5c1b23a82024-11-30Name fallback
brand name: Fingolimod
generic name: FINGOLIMOD
fingolimodFINGOLIMOD HCLRising Pharma Holdings, Inc.99e7daf4-ea90-5e47-e053-2a95a90ac1b72024-11-04Warnings, Adverse reactionsName fallback
brand name: fingolimod
FINGOLIMODFINGOLIMODSolco Healthcare US, LLC6c0faf2b-21fb-4830-bb78-5f2dbceb2c822024-07-31Warnings, Adverse reactionsName fallback
brand name: FINGOLIMOD
generic name: FINGOLIMOD
FingolimodFINGOLIMODXLCare Pharmaceuticals Inc.c5402dd1-c496-405d-9cae-07ccf184339c2024-06-20Warnings, Adverse reactionsName fallback
brand name: Fingolimod
generic name: FINGOLIMOD

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
64380-776FINGOLIMODfingolimodStrides Pharma Science LimitedANDACurrent