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 7 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC41da2e11-58c7-9622-e063-6394a90a9fdb2025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENACPHOENIX RX LLC41dab520-5651-a4c5-e063-6394a90a29622025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
Diclofenac SodiumDICLOFENAC SODIUMBluePoint Laboratoriesfeb1541a-de83-47dd-be03-c433765273182025-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Encube Ethicals, Inc.6e8c45e1-8cd4-4ff7-a758-f9d2ed37e5932025-10-01WarningsName fallback
brand name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEVINGDICLOFENAC SODIUMWalgreen Companyb1850a16-54f1-4210-abdf-26414da8b3d92025-09-29WarningsName fallback
generic name: DICLOFENAC SODIUM
FOSTER AND THRIVE ARTHRITIS PAINDICLOFENAC SODIUMStrategic Sourcing Services LLCf9f4e55f-ffad-4df7-9b3c-1e7c3a3723c12025-09-27WarningsName fallback
generic name: DICLOFENAC SODIUM
DG HEALTH ARTHRITIS PAINDICLOFENAC SODIUMDolgencorp Inc6479e4bb-0790-483e-bfe3-a54d549aa5d22025-09-15WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC3e15c3db-5245-76fb-e063-6394a90a814e2025-09-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions4c5b722e-0d1a-48e9-87c8-9b370b8ced462025-09-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack4e97c685-628a-4b83-ba9e-2d3caf65542b2025-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC3d71f76d-bb23-7251-e063-6394a90aa9d82025-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMBest Choice (Valu Merchandisers Company)4ea809a9-387a-4193-a176-d8b22eaa55e62025-08-21WarningsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsca0f9295-4933-48d6-9387-90345fd5dcaa2025-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%BluePoint Laboratories274543d2-a9a6-1e37-e063-6394a90ae3f12025-08-11WarningsName fallback
brand name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMRising Pharma Holdings, Inc.3330ea92-fc9d-4541-b378-be399b0995d32025-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC3a4f7301-aa1c-9064-e063-6294a90a6eb42025-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUM TOPICALPHOENIX RX LLC3a63e26f-27d7-9a25-e063-6294a90a55fe2025-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
DICLOFENAC SODIUMDICLOFENACEncube Ethicals, Inc.e7304b3e-530a-4519-aed0-bed4512d89252025-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC SODIUM
MEMBERS MARK ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMSam's West Incd339aaa2-ae7e-4a79-b687-cf0a3106fad02025-07-16WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMGolden State Medical Supply, Inc.39e67a90-df3e-ad30-e063-6394a90a7a822025-07-14Boxed warning, Warnings, Adverse reactionsName fallback
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