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 15 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac sodiumDICLOFENAC SODIUMCostco Wholesale141b6693-6d6c-45c6-9b82-ee1afcfca12a2023-01-27WarningsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Proficient Rx LPb4694451-a13d-484e-92c4-c03a6fcbb5112023-01-01WarningsName fallback
brand name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMProficient Rx LPb98d921a-2ee7-4770-ac21-d845b2dcc11c2023-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
Arthritis Pain RelieverDICLOFENAC SODIUMP & L Development, LLC2596645a-b736-4d3c-82a0-00713f1b6fbd2022-12-15WarningsName fallback
generic name: DICLOFENAC SODIUM
DiclofenacDICLOFENAC SODIUMAltaire Pharmaceuticals Inc.5372866a-dab3-45c8-8c2a-755ca36c17912022-10-28Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENACAsclemed USA, Inc.9df599de-6412-a94e-e053-2995a90a17412022-10-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
Diclofenac sodiumDICLOFENAC SODIUMAsclemed USA, Inc.d4b81a74-6926-4715-bf90-aec026cff2b42022-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.b162d65d-b105-4a68-90bb-316b9686267b2022-08-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMRite Aid Corporation1c9ea3b2-8f45-420b-87d3-dc7de0be2d5f2022-08-23WarningsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
diclofenac sodiumDICLOFENAC SODIUMProficient Rx LP67e384c6-8476-4aad-b967-241335538d562022-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LPafce2de2-0c59-4191-bf79-782ca31e427d2022-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions3a520306-fe3e-4830-963f-04b080db3abc2022-06-01Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
good sense arthritis painDICLOFENAC SODIUMProficient Rx LP67eacd91-8378-47e7-9bad-1e7b685aa9d42022-06-01WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP9eeb2aef-3eb1-4583-8180-d480deb3651c2022-05-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP1c1ee94c-60d6-4cfc-bb66-1d4f6e6305122022-05-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LP947c0c1f-3573-4f69-ab82-8b50c43e55862022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Arthritis Pain RelieverDICLOFENAC SODIUMCVS PHARMACY, INC047985ea-f768-4f9a-bfe3-0acf40a4781d2022-02-15WarningsName fallback
generic name: DICLOFENAC SODIUM
basic care arthritis painDICLOFENAC SODIUMAmazon.com Services LLCa8aa9016-bf2d-4727-9184-512b2570000b2022-01-06WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMSandoz Inc52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b2021-09-29Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMActavis Pharma, Inc.a57b897e-0cbe-4ac3-969f-b00357a0cfa82021-08-10Boxed 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.