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 8 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMSun Pharmaceutical Industries, Inc.f9a0c654-5f77-430f-b921-295eb776cbcd2025-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAdvagen Pharma Ltdac2b4060-a5da-4ddf-a734-2ff58a1f98c92025-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMSun Pharmaceutical Industries, Inc.aa1e1ed3-0444-4bf5-a0ee-5d21a7fca3912025-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
Arthritis Pain RelieverDICLOFENAC SODIUMChain Drug Consortium, LLC8879a2ed-6c66-4489-8adc-9f160241cc7d2025-06-25WarningsName fallback
generic name: DICLOFENAC SODIUM
kirkland signature arthritis pain reliefDICLOFENAC SODIUMCostco Wholesale Companyc30353da-acd6-474f-8a64-abd078bf4f852025-06-11WarningsName fallback
generic name: DICLOFENAC SODIUM
members mark arthritis pain relieverDICLOFENAC SODIUMSam's West Inc44533b5b-73ce-4853-9eda-506426cb9b822025-06-09WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMCarlsbad Technology, Inc.363764a0-e0a8-3e3f-e063-6294a90ad6722025-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENACAmneal Pharmaceuticals LLC45321aec-368d-4ca4-a0c5-2ce56fae74b22025-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMCarlsbad Technology, Inc.40879600-ba6c-43a8-aa5d-d0d41503d5932025-05-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMAurobindo Pharma Limited3487033c-7c62-4034-8718-73a7c49b26a02025-05-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC SODIUM
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMPD-Rx Pharmaceuticals, Inc.87d5a720-f154-4c4b-b2d4-0ae58455dda02025-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Dr. Reddy's Laboratories Inc.03abebd6-426a-9d05-3dff-1964773894302025-05-05WarningsName fallback
brand name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMBluePoint Laboratories896e3f7d-88e6-4563-b879-a2757d19fd622025-05-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMAdvagen Pharma Ltd72419a68-4c9d-44e0-9b43-922440e2c8d72025-04-30Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC SODIUM
generic name: DICLOFENAC SODIUM
up and up arthritis pain relieverDICLOFENAC SODIUMTarget Corporation0b7ae58c-cdaf-4343-a199-7a90bf901eb52025-04-27WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMNorthStar Rx LLCc7431496-c0ef-403a-9716-92d942709b3d2025-04-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMGERI-CARE PHARMACEUTICAL CORPfc08e58c-6323-e667-e053-6394a90ab7542025-04-21WarningsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMRedPharm Drug, Inc.4ecb7bdc-4a5e-7444-e054-00144ff88e882025-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack487fa223-f4d9-4ab1-a5af-fb0d93f2bd0e2025-03-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMINNOVUS PHARMACEUTICALS, INC.ad9d2c28-21bc-4f81-9c90-cce6a96d976a2025-03-25WarningsName 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