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 12 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack2bebda5e-227e-4a49-80e3-191cfc8052952024-08-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions203f96bb-ae63-475c-b7a6-03c0dbc435972024-08-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack12cce748-a7de-4b1e-9603-b5c2ce12d5312024-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack2b7462e6-62dc-4b08-9fbf-5858e356a7a82024-08-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMEXELAN PHARMACEUTICALS INC.be25c19e-cbea-4f87-a581-9f0d350e5adf2024-08-02WarningsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
diclofenac sodiumDICLOFENAC SODIUMPadagis Israel Pharmaceuticals Ltd3f0f3514-c3f7-4dab-8e5f-ddf89adbe3b82024-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.005299ac-b6de-511f-e063-6294a90a29e02024-07-29WarningsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.4b44ac98-225c-1739-e054-00144ff88e882024-07-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.abacf60f-0410-e6da-e053-2995a90a413c2024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENACAmneal Pharmaceuticals LLC78873f83-cea9-44d4-8ad4-8cb9257e5c7f2024-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
Diclofenac sodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC1d4d6370-2b45-fa6d-e063-6294a90a4a672024-07-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%NuCare Pharmaceuticals,Inc.0326ea5b-3e1a-dee2-e063-6294a90a13b82024-07-09WarningsName fallback
brand name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAurohealth LLC81e964ff-6622-4054-bf01-6ed6eef6778f2024-07-06WarningsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP898558e7-17f8-40cd-9dfc-67ddd64a5a422024-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMKROGER COMPANY15e59aac-a642-91e4-e063-6294a90a11752024-06-28WarningsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC1be247b8-dafd-ddf9-e063-6294a90aa9e12024-06-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Curist Arthritis ReliefDICLOFENAC SODIUMLittle Pharma, Inc.e638a98e-e6d7-36ed-e053-2995a90af2ca2024-06-21WarningsName fallback
generic name: DICLOFENAC SODIUM
diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.8721da56-0f8a-5903-e053-2991aa0a61b52024-06-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.8bda6135-c957-6b4e-e053-2995a90a0cb52024-06-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions5d74488c-e092-415d-b19b-05318380d9b12024-06-10Warnings, 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.