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 13 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.629b77cf-f825-8640-e053-2991aa0a10a82024-06-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack7bf19e84-4f75-4d5c-9927-99220c58b5722024-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUM TOPICALMedsource Pharmaceuticals1495ed53-0489-a465-e063-6394a90af68d2024-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
DICLOFENAC SODIUMDICLOFENAC SODIUMLupin Pharmaceuticals,Inc.7559928e-eeb8-47e8-8a55-d59e06bbc7372024-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC SODIUM
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Simple Diagnostics13925cd5-e121-80d2-e063-6394a90af9a92024-03-19WarningsName fallback
brand name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPf104f8fb-066f-4bbf-8894-3b3ed1b8266d2024-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepackdf5bb0e7-a3a9-4650-aae7-9a11ce615d5d2024-02-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMPadagis Israel Pharmaceuticals Ltd17bd62a8-b697-48cc-b988-aac3c19c6dc52024-01-22WarningsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack7c3d8d33-8849-44df-bb57-57d32b96a0e42024-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepackbced0ef0-085a-40db-9678-2bc6eb77d4562024-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENACAmneal Pharmaceuticals NY LLC1084e0c3-6d75-4090-84dc-02a18e0299b92023-12-29WarningsName fallback
brand name: Diclofenac sodium
Diclofenac SodiumDICLOFENAC SODIUM TOPICAL GEL, 1%,A-S Medication Solutions828b5de2-77a7-4893-ab47-dffc8ea736932023-12-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions50efc183-dd3e-4eb7-ba5c-c42fd76e0b652023-12-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMProficient Rx LPf19bf286-f4dd-4491-90c3-9f87130719032023-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC SODIUM
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMCVS Pharmacye9ccaf95-582b-4d4d-938f-7577eaa8dffb2023-11-27WarningsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepacke6a1ff58-a541-46f8-9663-eed53b7cf3922023-11-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions51756947-e802-4b4d-883e-fd6f22e9a7252023-10-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions9df87100-acf5-4b46-93b4-067b470136bd2023-10-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Arthritis Pain RelieverDICLOFENAC SODIUMCVS PHARMACY, INC4808015d-cfee-4f4d-a84b-82099f0b48682023-10-04WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions0379c918-1717-40ab-81cc-268116950fd52023-10-03Boxed 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.