FDA.reportPublic FDA data

Application 202027

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMSOLUTION;TOPICAL1.5%NoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A202027-001DICLOFENAC SODIUMDICLOFENAC SODIUM1.5%SOLUTION / TOPICAL2014-05-27

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A202027-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICAL2014-05-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202027-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICAL2014-05-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202027-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICAL2014-05-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202027-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICAL2014-05-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A202027-001AT174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A202027-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202027-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202027-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A202027-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202027-001AT1ea99ee380514…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VarophenDICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATEV2 Pharma, LLC1bef5035-70ad-4f75-80c3-6252cd01fa852024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202027
application number: ANDA202027
ndc (product): 72835-201

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4016Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50436-3990Diclofenac SodiumDiclofenac SodiumUnit Dose ServicesANDACurrent
60505-0399Diclofenac SodiumDiclofenac SodiumApotex Corp.ANDACurrent
60505-0399Diclofenac SodiumDiclofenac SodiumApotex Corp.ANDACurrent
60505-0399Diclofenac SodiumDiclofenac SodiumApotex Corp.ANDACurrent
60505-0399Diclofenac SodiumDiclofenac SodiumApotex Corp.ANDACurrent
60505-0399Diclofenac SodiumDiclofenac SodiumApotex Corp.ANDACurrent
60505-0399Diclofenac SodiumDiclofenac SodiumApotex Corp.ANDACurrent
61919-343DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent
61919-343DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent
68788-7097Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
69329-510Diclotral Pakdiclofenac sodium, capsaicinPatchwerx Labs, Inc.ANDACurrent
69837-399DICLOFENAC SODIUMDICLOFENAC SODIUMInternational Brand Management, LLCANDACurrent
69837-500Sure Result DSS Premium PakDICLOFENAC SODIUM, CAPSAICINInternational Brand Management, LLCANDACurrent
70518-0572Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0572Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0572Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0572Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
72835-201VarophenDiclofenac Sodium and Menthol, Methyl salicylateV2 Pharma, LLCANDACurrent
72835-201VarophenDiclofenac Sodium and Menthol, Methyl salicylateV2 Pharma, LLCANDACurrent
72835-201VarophenDiclofenac Sodium and Menthol, Methyl salicylateV2 Pharma, LLCANDACurrent