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 9 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUM TOPICALPreferred Pharmaceuticals Inc.6d5243ae-4a1a-4583-9337-085520e1f14a2025-03-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.c933eaad-ba53-4130-90db-a66f89dfc29f2025-03-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMOceanside Pharmaceuticalsc48113e0-9f1e-4086-b18f-3204c0d2a6892025-03-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMCipla USA Inc.daf52f5a-1bb7-4808-ab98-483ab9e8cfa02025-03-11WarningsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMAlembic Pharmaceuticals Limited048ede6a-b7cd-4100-8979-519bd44906c82025-03-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.31b56330-6870-48b7-a8c4-0639e0766b252025-03-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUM TOPICALAlembic Pharmaceuticals Limited11adfe0f-e774-4ccf-8a57-0c7d47aeb0dd2025-03-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
Voltaren Arthritis PainDICLOFENAC SODIUMHaleon US Holdings LLC30a94282-0892-442a-aa10-6525cbd4fe882025-02-11WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepackaf480e78-ff65-4709-af26-c430aefb77d62025-02-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.5508f80d-5f11-4959-8e42-9055f0169cfc2025-02-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.0d1d19e5-4ffe-af95-e063-6394a90a7abf2025-02-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPd70fcd8e-a72b-41ef-ac26-e0f2f279f0622025-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMActavis Pharma, Inc.74169b2d-ac56-4757-86c4-cdcfcd5f4eb52025-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMCoupler LLC2ce0741a-7bc7-8aec-e063-6294a90ae9ef2025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack49013aad-475c-4efb-84c6-15a5d4664fbf2025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Aspercreme ArthritisDICLOFENAC SODIUMChattem, Inc.762b7ef4-166c-43b8-9acd-2b9e7fa0bf362025-01-28WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMDirect_Rxf80b0b95-f4da-2d6c-e053-6294a90acf922025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMDirect_Rx0c41977f-8dad-1d26-e063-6294a90a9b222025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXa5b33bf7-8113-9c54-e053-2995a90a79d82025-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC SODIUM
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMAlembic Pharmaceuticals Inc.02e90e33-384f-4e29-b508-2503def222142025-01-17Boxed 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