FDA.reportPublic FDA data

Application 050735

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEORALCYCLOSPORINECAPSULE; ORAL25MGNoNo
002NEORALCYCLOSPORINECAPSULE; ORAL100MGNoNo

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CycloSPORINE, ModfiedCYCLOSPORINEApotex Corp.5baaf78c-90f6-abcf-52c8-814490f3cf9f2026-09-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEStrides Pharma Science Limitedc36132b2-3ec7-4c43-a25e-75cbdbe3d88d2026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
NeoralCYCLOSPORINENovartis Pharmaceuticals Corporation94461af3-11f1-4670-95d4-2965b9538ae32026-08-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Neoral
generic name: CYCLOSPORINE
SandimmuneCYCLOSPORINENovartis Pharmaceuticals Corporation5e5926a7-1de0-4b54-a5c0-286b6200ff822026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CEQUACYCLOSPORINESun Pharmaceutical Industries, Inc.48c3d8a3-4289-4b52-9189-58b48596095c2026-06-15Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
VerkaziaCYCLOSPORINEHarrow Eye, LLC48651d30-9e6e-74b0-e063-6294a90a83372026-06-03Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CYCLOSPORINECYCLOSPORINEUpsher-Smith Laboratories, LLCf7e4a2f0-ea2a-449b-bc6d-a6ea3d47b8502026-05-22Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEApotex Corp.bfca7088-fe93-abb9-3ec3-e6f5710a69c62026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CYCLOSPORINECYCLOSPORINESaptalis Pharmaceuticals, LLCff4dc2fc-667a-489a-b798-8d11cddfe7162025-12-09Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CYCLOSPORINECYCLOSPORINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1952d4c7-a40e-4924-b669-c41400774cb92025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
Restasis MultiDoseCYCLOSPORINEAllergan, Inc.7224d810-bb96-4682-a942-3355e6e8061a2025-08-21Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEDevatis Inc.7bb2078d-17c2-4e6a-9f61-26c7ecbce9452025-02-17Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
VerkaziaCYCLOSPORINESanten Incorporatedc795cd2f-89da-78e3-e053-2a95a90a94222025-01-17Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEApotex Corp70c8a4a6-ebe2-457f-a626-400c338cec2d2024-09-23Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEKVK-TECH, INC.a7040dc6-063b-40ee-8f2a-153e87b084302024-09-23Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
RESTASISCYCLOSPORINEAllergan, Inc.8e24af2b-bc1c-4849-94f2-6df950cdca892024-09-09Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CYCLOSPORINECYCLOSPORINELupin Pharmaceuticals, Inc.9aca2026-af86-4e97-925e-c202b87c46ac2024-09-01Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
GengrafCYCLOSPORINEAbbVie Inc.e896cbfe-4745-4088-82a3-8dc10b75c41f2024-08-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINETeva Pharmaceuticals USA, Inc.f3dc2a50-1084-4190-a6f3-37034a04db862024-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEDr. Reddy's Laboratories Inc64ec430a-e930-145c-e766-13fb49b646442024-06-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75582SUPPL 2023-09-27
75576SUPPL 2023-09-27