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 2 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.30c7e4fd-30af-4d28-a6ef-7386ff83cfb82026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAmerican Health Packagingdbb1489d-b690-4e53-905d-7fb07ad263b32026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEFDICLOFENAC SODIUMCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED84978746-4ab5-456d-af63-5c86ab0a05f52026-06-29WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.10991fe6-fafd-49af-9684-83b447c19c672026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMREMEDYREPACK INC.6980431d-4a2b-41e9-ae86-d46b4513f04b2026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMASCLEMED USA INC.53e8ad44-ff67-d3bb-e063-6394a90a524d2026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUM TOPICALREMEDYREPACK INC.cc8c3125-ee43-40bb-8500-339efa901b8c2026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
Diclofenac SodiumDICLOFENAC SODIUMSt. Mary's Medical Park Pharmacy5f4b69de-8ddd-26c5-e053-2a91aa0ab3262026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMGolden State Medical Supply, Inc.c1d87003-f54b-4381-9e11-1c39ea2d9eb32026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMCARDINAL HEALTH 110, LLC. DBA LEADER 70000081b43f9-f594-4b1e-8564-7dbbea6fa5bd2026-05-26WarningsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP1eb7a7bb-c524-4168-8ade-4601dc11533b2026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
arthritis pain relieverDICLOFENAC SODIUMHyVee Incbc74d53d-4142-4391-935b-61b7e353bd652026-04-30WarningsName fallback
generic name: DICLOFENAC SODIUM
TOPCARE ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMTopco Associates LLC1d6c4c38-3739-4d58-9811-bac09fcbfadb2026-04-24WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.7e940ce5-0f82-4d07-b507-c644481879c12026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMWalgreens33a37e3d-0463-428c-9169-240eeb77af2b2026-04-21WarningsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
EQUATE ARTHRITIS PAINDICLOFENAC SODIUMWALMART INC.d05b5f82-8772-4e01-8eb3-6fa6042f56612026-04-20WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMBryant Ranch Prepackb28e4a68-f396-4c1a-ba38-6a972906b4d02026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUM TOPICALASCLEMED USA INC.fd94964b-167b-41b7-a612-8febe9ae05112026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
DICLOFENAC SODIUMDICLOFENAC SODIUMREMEDYREPACK INC.96f8c42c-db34-43b0-a891-33dd8e39e74f2026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC SODIUM
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.e947653c-6789-4c15-82c9-4b1402f6d6ac2026-04-02Boxed 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