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 6 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMRedpharm Drug37362eb4-db16-f4ad-e063-6394a90a42aa2025-12-13WarningsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
UP AND UP ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMTarget Corporation3a9b32af-a3cd-496b-9698-0421443e03852025-12-08WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUM 1%SOLA Pharmaceuticalsbdbe3f24-3015-1f32-e053-2995a90aa6652025-12-08WarningsName fallback
brand name: Diclofenac Sodium
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC4539e9e7-5d82-3b36-e063-6394a90a13962025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Aleve Arthritis Pain GelDICLOFENAC SODIUMBayer HealthCare LLCbad675d1-1204-0136-e053-2995a90a994e2025-12-04WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUM TOPICALProficient Rx LP140a2c64-4996-4da3-b10f-1b8235ebde9d2025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
Diclofenac SodiumDICLOFENAC SODIUM TOPICALAlembic Pharmaceuticals Inc.30c3c3c5-b4f3-4321-ae25-b2c588ad05512025-11-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
Diclofenac SodiumDICLOFENAC SODIUMAurobindo Pharma Limitede5c0863a-edb7-4f46-a396-c9b2d8785cf82025-11-19WarningsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMSOLA Pharmaceuticals, LLCb8072af2-9940-4827-9fbd-de46ad8bf9292025-11-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMH E B027803c5-85ae-4b86-8bd4-e61f8f34d0362025-11-17WarningsName fallback
generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEVINGDICLOFENAC SODIUMMeijer, Inc.5cc570c6-2585-4d1a-9352-b1161458af9a2025-11-17WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMPHOENIX RX LLC41472cca-278b-934b-e063-6294a90aaf5d2025-11-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC4382cc15-8978-4f3b-e063-6394a90a9ecb2025-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Topical 1%DICLOFENAC SODIUMYYBA CORP043df5d2-6f3e-311f-e063-6294a90a23d72025-11-10WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC0b4fd47f-903c-097b-e063-6394a90a49ab2025-11-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMLupin Pharmaceuticals, Inc.609c5344-9c97-4fa8-ad53-d0f622ce64ec2025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Dr. Reddy's Laboratories Inc.c88b2512-0255-658d-252a-c006275159b02025-10-28WarningsName fallback
brand name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Chain Drug Marketing Association INC625d21e8-0731-1157-30fe-9f9868ff8dc42025-10-28WarningsName fallback
brand name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%GERI-CARE PHARMACEUTICALS CORP91fc618a-edd0-5944-083f-c00075476f552025-10-28WarningsName fallback
brand name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMGLENMARK PHARMACEUTICALS INC., USAdab3ae60-0135-43b3-a1d0-8752720af82a2025-10-27Boxed 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