FDA.reportPublic FDA data

Application 219049

Type
ANDA
Sponsor
QILU

Application Products#

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

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
A219049-001CYCLOSPORINECYCLOSPORINE25MGCAPSULE / ORALAB12025-09-15
A219049-002CYCLOSPORINECYCLOSPORINE100MGCAPSULE / ORALAB12025-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A219049-001AB1
A219049-002AB1

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 UTC2026-02A219049-001CYCLOSPORINE25MGCAPSULE / ORALAB12025-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219049-002CYCLOSPORINE100MGCAPSULE / ORALAB12025-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219049-001CYCLOSPORINE25MGCAPSULE / ORALAB12025-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219049-002CYCLOSPORINE100MGCAPSULE / ORALAB12025-09-1531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219049-001CYCLOSPORINE25MGCAPSULE / ORALAB12025-09-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219049-002CYCLOSPORINE100MGCAPSULE / ORALAB12025-09-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219049-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219049-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219049-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219049-002AB1131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219049-001AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219049-002AB11a50c72e98297…

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 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeoralCYCLOSPORINENovartis Pharmaceuticals Corporation94461af3-11f1-4670-95d4-2965b9538ae32026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
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
brand name: CYCLOSPORINE
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEApotex Corp.bfca7088-fe93-abb9-3ec3-e6f5710a69c62026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cyclosporine
generic name: CYCLOSPORINE
CYCLOSPORINECYCLOSPORINESaptalis Pharmaceuticals, LLCff4dc2fc-667a-489a-b798-8d11cddfe7162025-12-09Warnings, Adverse reactionsName fallback
brand name: CYCLOSPORINE
generic name: CYCLOSPORINE
CYCLOSPORINECYCLOSPORINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1952d4c7-a40e-4924-b669-c41400774cb92025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CYCLOSPORINE
generic name: CYCLOSPORINE
CycloSPORINE, ModfiedCYCLOSPORINEApotex Corp.5baaf78c-90f6-abcf-52c8-814490f3cf9f2025-09-17Boxed 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
brand name: Cyclosporine
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
brand name: Cyclosporine
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEKVK-TECH, INC.a7040dc6-063b-40ee-8f2a-153e87b084302024-09-23Warnings, Adverse reactionsName fallback
brand name: Cyclosporine
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
brand name: CYCLOSPORINE
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
brand name: Cyclosporine
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEDr. Reddy's Laboratories Inc64ec430a-e930-145c-e766-13fb49b646442024-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cyclosporine
generic name: CYCLOSPORINE
RESTASISCYCLOSPORINEA-S Medication Solutionsee57c1c0-2fcd-4628-8e33-4e0a9dadcb032024-05-24Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE