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 4 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLOFENAC SODIUMDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.06862cf2-9537-6661-e063-6294a90a20842026-02-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC SODIUM
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack03c4f06f-6a49-4404-bf3b-0aafa33c81ef2026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMRugby Laboratories95f3c70c-eded-4d24-b9b0-cfa0b7902d6e2026-02-10WarningsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Sportpharm LLCa133d18e-981d-43b7-bef1-7869f7c7d9a72026-02-09WarningsName fallback
brand name: DICLOFENAC SODIUM
diclofenac sodiumDICLOFENAC SODIUMREMEDYREPACK INC.6aab6c1f-9b02-4101-b7c8-ab7a557043202026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMSOLA Pharmaceuticals, LLC11e88ced-cdcf-4101-9297-c4c3dde9d0892026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMSportpharm LLC99f1e69e-02cf-49c2-83af-3cccbbea42152026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions0cefb675-c54e-44eb-b35c-38354b77eddd2026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions74011b00-7e2e-40a7-ab30-c05a205598142026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMUmedica Laboratories USA Inc.0e5c6669-390f-4c32-b9b8-13ed3c5174622026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Arthritis Pain RelieverDICLOFENAC SODIUMFamily Dollar (FAMILY WELLNESS)03ddf347-a3a3-4313-87d1-a246c1d4e0b42026-01-29WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMGolden State Medical Supply, Inc.468fab22-2b69-4a2c-e063-6294a90aab9a2026-01-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMBausch & Lomb Incorporated39dfffb0-612a-48f3-8db5-1a59899b91e92026-01-27Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMIngenus Pharmaceuticals, LLC1a237198-ca24-4159-b570-b5a23c8e91b02026-01-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.4ee64a93-9965-47c8-be2c-14232df44b2b2026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMA-S Medication Solutionsf92576d7-3ad9-43a3-8b10-3a29fbf712a42026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC SODIUM
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMA-S Medication Solutions6c57e330-ebbe-4165-84a8-4844b2f0097e2026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC SODIUM
generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMPublix Super Markets Incbae07276-c800-468e-a201-e6268846fff32026-01-15WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions47793dca-5e9e-44ee-8e66-5e42e1831b1e2026-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsb74be49d-74ff-491b-962b-0edd3a57cbc92026-01-15Boxed 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