FDA.reportPublic FDA data

Application 209903

Type
ANDA
Sponsor
CIPLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMGEL;TOPICAL1%NoNo

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
A209903-001DICLOFENAC SODIUMDICLOFENAC SODIUM1%GEL / TOPICAL2018-08-03

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 UTC2022-10A209903-001DICLOFENAC SODIUM1%GEL / TOPICAL2018-08-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209903-001DICLOFENAC SODIUM1%GEL / TOPICAL2018-08-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209903-001DICLOFENAC SODIUM1%GEL / TOPICAL2018-08-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209903-001DICLOFENAC SODIUM1%GEL / TOPICAL2018-08-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-04 05:41 UTC2022-04A209903-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209903-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209903-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209903-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209903-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209903-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209903-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209903-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209903-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209903-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209903-001AB1ea99ee380514…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.57c83158-f072-6fa2-e063-6394a90aee2c2026-07-29WarningsExact identifier
application applno (ANDA): 209903
application number: ANDA209903
Diclofenac sodiumDICLOFENAC SODIUMCipla USA Inc.daf52f5a-1bb7-4808-ab98-483ab9e8cfa02025-03-11WarningsExact identifier
application applno (ANDA): 209903
application number: ANDA209903
Diclofenac SodiumDICLOFENAC SODIUMQuality Care Products, LLC12e1f808-9f24-4f6d-b5bc-12ce0059ab7a2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209903
application number: ANDA209903
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.200c2800-a703-e138-e063-6394a90acc092024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209903
application number: ANDA209903
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions203f96bb-ae63-475c-b7a6-03c0dbc435972024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209903
application number: ANDA209903
ndc (product): 50090-4030
Diclofenac SodiumDICLOFENAC SODIUMEXELAN PHARMACEUTICALS INC.be25c19e-cbea-4f87-a581-9f0d350e5adf2024-08-02WarningsExact identifier
application applno (ANDA): 209903
application number: ANDA209903
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions51756947-e802-4b4d-883e-fd6f22e9a7252023-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209903
application number: ANDA209903
ndc (product): 50090-4020

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 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-976Diclofenac sodiumDiclofenac sodiumNorthStar RxLLCANDACurrent
16714-976Diclofenac sodiumDiclofenac sodiumNorthStar RxLLCANDACurrent
50090-4020Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-4020Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-4020Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-4021Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-4030Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-4030Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-4030Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-5075Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-5077Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
68788-7433Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7433Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7433Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7433Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
69097-524Diclofenac SodiumDiclofenac SodiumCipla USA Inc.ANDACurrent
69097-524Diclofenac SodiumDiclofenac SodiumCipla USA Inc.ANDACurrent
69097-524Diclofenac SodiumDiclofenac SodiumCipla USA Inc.ANDACurrent
69097-524Diclofenac SodiumDiclofenac SodiumCipla USA Inc.ANDACurrent
69097-524Diclofenac SodiumDiclofenac SodiumCipla USA Inc.ANDACurrent
69097-524Diclofenac SodiumDiclofenac SodiumCipla USA Inc.ANDACurrent
69097-524Diclofenac SodiumDiclofenac SodiumCipla USA Inc.ANDACurrent
71335-1226Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
76282-663Diclofenac SodiumDiclofenac SodiumEXELAN PHARMACEUTICALS INC.ANDACurrent
76282-663Diclofenac SodiumDiclofenac SodiumEXELAN PHARMACEUTICALS INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79915SUPPL 2024-10-21