Application 090066

Type
ANDA
Sponsor
UNIQUE PHARM LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL25MGNoYes
002DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL50MGNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A090066-001DICLOFENAC SODIUMDICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01
A090066-002DICLOFENAC SODIUMDICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090066-001AB
A090066-002AB

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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2010-12-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2010-12-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090066-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01782e0a99824c…
2021-12-28 21:50 UTC2021-12A090066-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALABRS2010-12-01782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090066-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090066-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090066-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090066-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090066-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090066-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090066-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090066-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090066-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090066-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090066-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090066-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090066-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090066-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090066-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090066-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090066-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090066-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090066-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090066-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090066-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090066-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090066-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090066-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090066-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090066-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090066-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090066-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090066-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090066-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090066-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090066-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090066-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090066-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090066-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090066-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090066-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090066-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090066-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090066-002AB1782e0a99824c…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMAmerican Health Packaging63c00b50-06d3-4659-81cf-be4516429e812026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
ndc (product): 60687-606
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.4ee64a93-9965-47c8-be2c-14232df44b2b2026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions1e669fc2-69bf-4439-a336-a103e5b9cafe2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions8825dc2c-3497-455f-b5e1-2aa6672919572026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
ndc (product): 50090-0540
Diclofenac SodiumDICLOFENAC SODIUMBluePoint Laboratoriesfeb1541a-de83-47dd-be03-c433765273182025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
ndc (product): 68001-279
ndc (product): 68001-280
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack4e97c685-628a-4b83-ba9e-2d3caf65542b2025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
Diclofenac SodiumDICLOFENAC SODIUMRising Pharma Holdings, Inc.3330ea92-fc9d-4541-b378-be399b0995d32025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
ndc (product): 16571-203
ndc (product): 16571-202
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepackaf480e78-ff65-4709-af26-c430aefb77d62025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLCb3dbd981-453c-645f-e053-2a95a90aec3c2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
ndc (product): 80425-0102
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP9eeb2aef-3eb1-4583-8180-d480deb3651c2022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090066
application number: ANDA090066
ndc (product): 63187-714

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-934Diclofenac SodiumDiclofenac SodiumBlenheim Pharmacal, Inc.ANDACurrent
16571-202Diclofenac SodiumDiclofenac SodiumRising Pharmaceuticals, Inc.ANDACurrent
16571-202Diclofenac SodiumDiclofenac SodiumRising Pharmaceuticals, Inc.ANDACurrent
16571-202Diclofenac SodiumDiclofenac SodiumRising Pharma Holdings, Inc.ANDACurrent
16571-202Diclofenac SodiumDiclofenac SodiumRising Pharma Holdings, Inc.ANDACurrent
16571-203Diclofenac SodiumDiclofenac SodiumRising Pharmaceuticals, Inc.ANDACurrent
16571-203Diclofenac SodiumDiclofenac SodiumRising Pharmaceuticals, Inc.ANDACurrent
16571-203Diclofenac SodiumDiclofenac SodiumRising Pharma Holdings, Inc.ANDACurrent
16571-203Diclofenac SodiumDiclofenac SodiumRising Pharma Holdings, Inc.ANDACurrent
35356-725Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-725Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-725Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-725Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-725Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-725Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-725Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0540Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
60687-606Diclofenac SodiumDiclofenac SodiumAmerican Health PackagingANDACurrent
60687-606Diclofenac SodiumDiclofenac SodiumAmerican Health PackagingANDACurrent
61919-575DICLOFENAC SODIUMDICLOFENAC SODIUMDirectRXANDACurrent
61919-575DICLOFENAC SODIUMDICLOFENAC SODIUMDirectRXANDACurrent
63187-714Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63187-714Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63187-714Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63187-714Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
67296-1064Diclofenac SodiumDiclofenac SodiumRedPharm Drug, Inc.ANDACurrent
67296-1064Diclofenac SodiumDiclofenac SodiumRedPharm Drug, Inc.ANDACurrent
67296-1064Diclofenac SodiumDiclofenac SodiumRedPharm Drug, Inc.ANDACurrent
68001-279Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-279Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-279Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-279Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-279Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-280Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-280Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-280Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-280Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-280Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68151-0849Diclofenac SodiumDiclofenac SodiumCarilion Materials ManagementANDACurrent
68788-9175Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
80425-0102VoltarenDiclofenac Sodium 50mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0102VoltarenDiclofenac Sodium 50mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0102Diclofenac SodiumDiclofenac SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0102Diclofenac SodiumDiclofenac SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0102Diclofenac SodiumDiclofenac SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent