FDA.reportPublic FDA data

Application 075281

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL50MGNoNo
003DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL75MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075281-002DICLOFENAC SODIUMDICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2002-02-12
A075281-003DICLOFENAC SODIUMDICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2002-02-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075281-002AB
A075281-003AB

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A075281-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL2002-02-12f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A075281-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL2002-02-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075281-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL2002-02-12e64feba35796…
2022-09-29 23:25 UTC2022-09A075281-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL2002-02-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075281-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORAL2002-02-12cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075281-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORAL2002-02-12cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075281-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2002-02-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075281-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2002-02-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A075281-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A075281-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A075281-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A075281-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A075281-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075281-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075281-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075281-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075281-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075281-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075281-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075281-003AB16a471c1ec25d…
2019-12-13 00:20 UTC2019-12A075281-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075281-003AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A075281-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075281-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075281-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075281-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075281-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075281-003AB1ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075281-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075281-003AB1a50c72e98297…

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.5a852412-69af-6502-e063-6294a90a07482026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075281
application number: ANDA075281
DICLOFENAC SODIUMDICLOFENAC SODIUMNorthwind Health Company, LLC5990259d-2f90-20d3-e063-6394a90a3d232026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075281
application number: ANDA075281
DICLOFENAC SODIUMDICLOFENAC SODIUMNorthwind Health Company, LLC4dde6e36-7540-1cc3-e063-6294a90a39412026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075281
application number: ANDA075281
DICLOFENAC SODIUMDICLOFENAC SODIUMREMEDYREPACK INC.6e6a6f98-5517-4f67-9a6a-71019ba2d7732026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075281
application number: ANDA075281
DICLOFENAC SODIUMDICLOFENAC SODIUMA-S Medication Solutionsf92576d7-3ad9-43a3-8b10-3a29fbf712a42026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075281
application number: ANDA075281
DICLOFENAC SODIUMDICLOFENAC SODIUMA-S Medication Solutions6c57e330-ebbe-4165-84a8-4844b2f0097e2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075281
application number: ANDA075281
DICLOFENAC SODIUMDICLOFENAC SODIUMAurobindo Pharma Limited3487033c-7c62-4034-8718-73a7c49b26a02025-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075281
application number: ANDA075281

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6280Diclofenac Sodiumdiclofenac sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6280Diclofenac Sodiumdiclofenac sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6281Diclofenac Sodiumdiclofenac sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6281Diclofenac Sodiumdiclofenac sodiumMylan Pharmaceuticals Inc.ANDACurrent
51079-224Diclofenac Sodiumdiclofenac sodiumMylan Institutional Inc.ANDACurrent
51079-224Diclofenac Sodiumdiclofenac sodiumMylan Institutional Inc.ANDACurrent
51079-466Diclofenac Sodiumdiclofenac sodiumMylan Institutional Inc.ANDACurrent
68788-9185Diclofenac Sodiumdiclofenac sodiumPreferred Pharmaceuticals, Inc.ANDACurrent