FDA.reportPublic FDA data

Application 207393

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENACDICLOFENACCAPSULE;ORAL18MGNoNo
002DICLOFENACDICLOFENACCAPSULE;ORAL35MGNoNo

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 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiclofenacDICLOFENAC SODIUMYYBA CORP533653e8-93d5-9080-e063-6394a90a165b2026-09-01WarningsName fallback
brand name: Diclofenac
Diclofenac SodiumDICLOFENACPreferred Pharmaceuticals Inc.937e9ba5-cdad-4e72-a77a-bad699e1b2362026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
XicloDICLOFENACStrand Health Group2d93a01c-40a9-8fb0-e063-6394a90a2cc62025-12-18WarningsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACPHOENIX RX LLC41dab520-5651-a4c5-e063-6394a90a29622025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
DICLOFENAC SODIUMDICLOFENACEncube Ethicals, Inc.e7304b3e-530a-4519-aed0-bed4512d89252025-07-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
XicloDICLOFENACAsclemed USA, Inc.71cd0d4e-671c-4372-9b1f-7b34cf8878242025-06-07WarningsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACAmneal Pharmaceuticals LLC45321aec-368d-4ca4-a0c5-2ce56fae74b22025-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
Diclofenac DRDICLOFENACAdvanced Rx of Tennessee, LLCaf8a30fb-ead8-7e29-e053-2a95a90a040f2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACAdvanced Rx Pharmacy of Tennessee, LLCfc100cb2-16d9-f67d-e053-6294a90a0f2e2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
Diclofenac sodiumDICLOFENACScholl's Wellness Company8dcbce69-945b-4913-a279-ee10871f65802024-11-14WarningsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACAmneal Pharmaceuticals LLC78873f83-cea9-44d4-8ad4-8cb9257e5c7f2024-07-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
Diclofenac sodiumDICLOFENACAmneal Pharmaceuticals NY LLC1084e0c3-6d75-4090-84dc-02a18e0299b92023-12-29WarningsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACProficient Rx LPf4da38af-c5bd-4d4a-a6f3-c2933f2238092023-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACBryant Ranch Prepacke5f8284a-1aa9-4a36-a6ad-fa153c613f342023-05-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACA-S Medication Solutions58178f0d-3960-48e3-91ba-150f691be2412023-05-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
DiclofenacDICLOFENAC SODIUMAltaire Pharmaceuticals Inc.5372866a-dab3-45c8-8c2a-755ca36c17912022-10-28Warnings, Adverse reactionsName fallback
brand name: Diclofenac
Diclofenac SodiumDICLOFENACAsclemed USA, Inc.9df599de-6412-a94e-e053-2995a90a17412022-10-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC

Reported adverse events (FAERS/openFDA)#

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