FDA.reportPublic FDA data

Application 203786

Type
ANDA
Sponsor
VERSAPHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMSOLUTION;TOPICAL1.5% W/WNoNo

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 14 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac sodiumDICLOFENAC SODIUMAsclemed USA, Inc.6a9c3cea-7b46-427d-99af-90c1f290b1902023-09-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
equaline arthritis pain relievingDICLOFENAC SODIUMUnited Natural Foods, Inc. dba UNFI748b6134-0c1d-4e9c-a93a-fcc6e4d0b6d02023-08-23WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAurohealth LLC2a599579-b2b0-4423-8e30-fe04bf8158702023-08-11WarningsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Arthritis Pain RelieverDICLOFENAC SODIUMAmerisourceBergen (Good Neighbor Pharmacy) 4612230e1f589-b322-48b7-9a97-502afe2a1baa2023-08-09WarningsName fallback
generic name: DICLOFENAC SODIUM
equate arthritis painDICLOFENAC SODIUMWal-Mart Stores Inc5e80f6b6-b3f4-4b76-82da-1fc98cb9ad1b2023-07-27WarningsName fallback
generic name: DICLOFENAC SODIUM
berkley and jensen arthritis painDICLOFENAC SODIUMBJWC441cf367-b293-47e8-a8fb-32e3314be7de2023-07-26WarningsName fallback
generic name: DICLOFENAC SODIUM
diclofenac sodiumDICLOFENAC SODIUMBryant Ranch Prepack16853c78-493a-4b8b-87b9-97dc927e1c8e2023-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: diclofenac sodium
generic name: DICLOFENAC SODIUM
CareOne arthritis pain reliefDICLOFENAC SODIUMAmerican Sales Company69615972-b593-44fb-ae49-9441d872d84a2023-06-08WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENACProficient Rx LPf4da38af-c5bd-4d4a-a6f3-c2933f2238092023-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
Diclofenac SodiumDICLOFENACBryant Ranch Prepacke5f8284a-1aa9-4a36-a6ad-fa153c613f342023-05-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
DG health arthritis painDICLOFENAC SODIUMDolgencorp Ince7f93d8f-df2b-4005-b58d-c6f10ae0e0f32023-05-24WarningsName fallback
generic name: DICLOFENAC SODIUM
arthritis pain relieverDICLOFENAC SODIUMPublix Super Markets Inc445de976-9a28-4e97-929f-c77aeb21c1fa2023-05-15WarningsName fallback
generic name: DICLOFENAC SODIUM
arthritis pain relievingDICLOFENAC SODIUMMeijer Distribution Incd46a4841-2f86-4e0e-ac79-9b1444ed4f792023-05-15WarningsName fallback
generic name: DICLOFENAC SODIUM
topcare athritis pain relieverDICLOFENAC SODIUMTopco Associates LLCd3e9416d-e13b-4cc7-a663-6df3534b8dbe2023-05-10WarningsName fallback
generic name: DICLOFENAC SODIUM
good sense arthritis painDICLOFENAC SODIUML. Perrigo Company7b32b9e4-6502-4fa3-808f-3bef9525b6a12023-05-10WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENACA-S Medication Solutions58178f0d-3960-48e3-91ba-150f691be2412023-05-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
arthritis pain relieverDICLOFENAC SODIUMH E Be8fe4a89-586d-461c-b242-b68e38a508b42023-03-09WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMQuality Care Products LLC94422b85-28ed-477f-853a-71d1d6cf17d52023-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LP73a46413-ecbc-4453-814d-bec955b375d22023-02-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPb41335b6-859f-4568-84d2-0d0408415a4e2023-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM

Reported adverse events (FAERS/openFDA)#

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