FDA.reportPublic FDA data

Application 207940

Type
ANDA
Sponsor
STANDARD CHEM AND PHARM CO LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FINGOLIMODFINGOLIMODCAPSULE;ORALEQ 0.5MG BASENoNo

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
FingolimodFINGOLIMODNovadoz Pharmaceuticals LLCbd981e18-1766-4a2d-9a9b-965ec960aa062026-08-27Warnings, Adverse reactionsName fallback
brand name: Fingolimod
generic name: FINGOLIMOD
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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67808ORIG2021-06-15