FDA.reportPublic FDA data

Application 075152

Type
ANDA
Sponsor
WATSON LABS TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMTABLET;ORAL50MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075152-001DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM50MGTABLET / ORAL1998-11-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A075152-001DICLOFENAC POTASSIUM50MGTABLET / ORAL1998-11-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075152-001DICLOFENAC POTASSIUM50MGTABLET / ORAL1998-11-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075152-001DICLOFENAC POTASSIUM50MGTABLET / ORAL1998-11-27a50c72e98297…

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 1 of 4 · 66 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDAmerisyn LLCb0931350-28a9-4f00-9254-1d72e31f04c32026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC POTASSIUM
Diclofenac PotassiumDICLOFENAC POTASSIUMPar Health USA, LLC2d45648f-cbea-41a4-8e3e-007b7bb7912c2026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Potassium
generic name: DICLOFENAC POTASSIUM
Diclofenac PotassiumDICLOFENAC POTASSIUMSun Pharmaceutical Industries, Inc.68a926a2-b818-420f-9c9a-fd91dc5a8f362026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Potassium
generic name: DICLOFENAC POTASSIUM
diclofenac potassiumDICLOFENAC POTASSIUMStrides Pharma Science Limited2184805c-b9b3-4be8-8726-4ce1b11974772026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: diclofenac potassium
generic name: DICLOFENAC POTASSIUM
Diclofenac PotassiumDICLOFENAC POTASSIUMREMEDYREPACK INC.c4976d69-ca06-4263-9240-6fd8b44a9b6d2026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Potassium
generic name: DICLOFENAC POTASSIUM
Diclofenac PotassiumDICLOFENAC POTASSIUMNuCare Pharmaceuticals,Inc.d61cbb27-737d-948c-e053-2a95a90adaca2026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Potassium
generic name: DICLOFENAC POTASSIUM
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDVICI Pharmaceuticals, Inc544a869e-60ef-627b-e063-6294a90a3fd82026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC POTASSIUM
Diclofenac PotassiumDICLOFENAC POTASSIUMBryant Ranch Prepack86461915-9bc1-43d4-8d92-6eef3e56bd902026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Potassium
generic name: DICLOFENAC POTASSIUM
Diclofenac PotassiumDICLOFENAC POTASSIUMBryant Ranch Prepacke29e7aea-0bcd-46e5-b011-fbaf5aa2244a2026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Potassium
generic name: DICLOFENAC POTASSIUM
Diclofenac PotassiumDICLOFENAC POTASSIUM TABLETSUmedica Laboratories USA Inc.1fa07fbe-3708-4200-b3ff-a920434896b62026-04-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Potassium
Diclofenac PotassiumDICLOFENAC POTASSIUM 25 MGPureTek Corporation4a828eb5-0383-f524-e063-6394a90a84492026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Potassium
Diclofenac PotassiumDICLOFENAC POTASSIUM TABLETSBryant Ranch Prepack94898228-c595-4fd6-acc2-13dbdbde9c0e2026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Potassium
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMTorrent Pharmaceuticals Limited6a945fa8-6c62-40ba-ae97-b994cc90583e2026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC POTASSIUM
generic name: DICLOFENAC POTASSIUM
ZIPSORDICLOFENAC POTASSIUMAssertio Specialty Pharmaceuticals LLCed2a8868-78eb-47b8-8f46-0f70e2891e072026-03-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC POTASSIUM
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMUmedica Laboratories USA Inc.33930285-dd97-415c-9e2a-491bd7b12af92026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC POTASSIUM
generic name: DICLOFENAC POTASSIUM
Diclofenac PotassiumDICLOFENAC POTASSIUMAvKARE21dc9953-4e6d-50f0-e063-6294a90ac4ef2026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Potassium
generic name: DICLOFENAC POTASSIUM
Diclofenac PotassiumDICLOFENAC POTASSIUMPHOENIX RX LLC43448b74-6c02-a581-e063-6394a90a63ba2026-01-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Potassium
generic name: DICLOFENAC POTASSIUM
Diclofenac PotassiumDICLOFENAC POTASSIUM TABLETSZydus Pharmaceuticals (USA) Inc.1aa3d8d6-dd1c-46c7-96f9-2b5c9d72764a2026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Potassium
Diclofenac PotassiumDICLOFENAC POTASSIUMSOLA Pharmaceuticals, LLCe770efc8-bbad-4103-98e4-e31019a540f52026-01-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Potassium
generic name: DICLOFENAC POTASSIUM
Diclofenac PotassiumDICLOFENAC POTASSIUMNorthwind Health Company, LLCf2b6a4dd-e4e2-4acc-e053-2995a90aebf22026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Potassium
generic name: DICLOFENAC POTASSIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8539ORIG1998-11-27