FDA.reportPublic FDA data

Application 207238

Type
ANDA
Sponsor
ACTAVIS LABS UT INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMSOLUTION;TOPICAL2%NoNo

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 11 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMQuality Care Products, LLC12e1f808-9f24-4f6d-b5bc-12ce0059ab7a2024-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLCf18a4691-93a1-01e6-e053-2995a90a00692024-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, LLC.26e44aa5-cfcd-f10b-e063-6394a90a4dcf2024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENACScholl's Wellness Company8dcbce69-945b-4913-a279-ee10871f65802024-11-14WarningsName fallback
brand name: Diclofenac sodium
SalonpasDICLOFENAC SODIUMHisamitsu America, Inc.f439445d-046e-4220-a4a7-13d750ee09492024-11-14WarningsName fallback
generic name: DICLOFENAC SODIUM
MOTRIN ARTHRITIS PAINDICLOFENAC SODIUMKenvue Brands LLCdb5b4288-13ec-826b-e053-2995a90a275e2024-11-08WarningsName fallback
generic name: DICLOFENAC SODIUM
diclofenac sodiumDICLOFENAC SODIUMBryant Ranch Prepackbf372e32-0902-447f-9673-00a3fcf0064c2024-11-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPba4677e4-00f8-44f6-a69b-e88ca28f6b2b2024-11-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
kirkland signature arthritis pain reliefDICLOFENAC SODIUMCostco Wholesale Company8e53e5fa-fda2-4e3a-8c5a-82435e3d51c32024-11-01WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepackae0add8e-3a8a-4c5d-af3b-907f64211fef2024-10-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions70156824-e5dd-42b1-9b4f-a49acb28d3162024-10-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc2e3e6de9-7e07-4df3-9fea-ac50ddcde8402024-10-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPf5b4e308-c156-4865-95ee-1a8e267535ba2024-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
good sense arthritis painDICLOFENAC SODIUMA-S Medication Solutions5f1ca9c1-c7fe-4a91-af5e-dc22b175f0832024-09-26WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUM TOPICAL GEL, 1%,A-S Medication Solutions4500bf3c-394b-4397-8751-8dac2097fc412024-09-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
Diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.22f4b8aa-902f-a860-e063-6394a90ada262024-09-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
Gencare-Arthritis Pain ReliefDICLOFENAC SODIUMPioneer Life Sciences, LLC4b1438bb-8591-4237-abcb-91491f34ad8f2024-09-10WarningsName fallback
generic name: DICLOFENAC SODIUM
diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.20ef08a3-35cf-b4d6-e063-6394a90a012e2024-08-30WarningsName fallback
brand name: diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMHarris Teeter17ed520d-bfbe-4a33-e063-6394a90aa0f62024-08-30WarningsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.200c2800-a703-e138-e063-6394a90acc092024-08-19Boxed 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.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48404ORIG2017-05-17
48395ORIG2017-05-17