Application 076004

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ETODOLACETODOLACTABLET;ORAL400MGNoNo
002ETODOLACETODOLACTABLET;ORAL500MGNoNo

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
A076004-001ETODOLACETODOLAC400MGTABLET / ORALAB2002-12-03
A076004-002ETODOLACETODOLAC500MGTABLET / ORALAB2002-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076004-001AB
A076004-002AB

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 UTC2026-02A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076004-001ETODOLAC400MGTABLET / ORALAB2002-12-03782e0a99824c…
2021-12-28 21:50 UTC2021-12A076004-002ETODOLAC500MGTABLET / ORALAB2002-12-03782e0a99824c…

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 UTC2026-02A076004-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076004-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076004-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076004-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076004-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076004-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076004-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076004-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076004-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076004-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076004-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076004-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076004-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076004-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076004-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076004-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076004-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076004-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076004-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076004-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076004-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076004-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076004-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076004-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076004-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076004-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076004-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076004-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076004-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076004-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076004-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076004-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076004-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076004-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076004-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076004-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076004-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076004-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076004-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076004-002AB1782e0a99824c…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EtodolacETODOLACSt. Marys Medical Park Pharmacy60cb4de0-ed88-a46b-e053-2a91aa0a8b6d2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
ndc (product): 60760-552
EtodolacETODOLACREMEDYREPACK INC.cad9b5ca-a9d4-41d4-aff2-67d0c458aad62026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
EtodolacETODOLACPD-Rx Pharmaceuticals, Inc.007c55fa-ef8b-4a8e-bfe5-e47c6e5da7272026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
ndc (product): 43063-856
EtodolacETODOLACPD-Rx Pharmaceuticals, Inc.41bd86b9-2ef3-49a4-874e-fe8ac68910802026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
ndc (product): 43063-671
EtodolacETODOLACPD-Rx Pharmaceuticals, Inc.556eaa67-d30d-4095-a981-c65f98d3acdd2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
ndc (product): 43063-578
EtodolacETODOLACREMEDYREPACK INC.1a38815e-1903-4f03-b83e-9780c71d49712025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
EtodolacETODOLACPD-Rx Pharmaceuticals, Inc.80e9d756-9278-48bb-bfdd-7d070ae0f3412025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
EtodolacETODOLACBryant Ranch Prepack479bce92-2066-46ed-b4bb-8c7a59edfffd2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
ndc (product): 63629-8805
EtodolacETODOLACApotex Corp.4d682f98-1e8a-4c2b-6df3-169d2ed10dc12025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
ndc (product): 60505-0041
ndc (product): 60505-0102
EtodolacETODOLACPreferred Pharmaceuticals Inc.556a7d5f-2c3c-4efb-ac0c-fca1407916022025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
EtodolacETODOLACAdvanced Rx Pharmacy of Tennessee, LLCd83d9f30-c367-f8b3-e053-2a95a90a1f402024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
EtodolacETODOLACBryant Ranch Prepackbe53bc5c-4294-44a7-b28c-7db3f925396d2024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC141be3f6-198d-ce46-e063-6294a90a79932024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
EtodolacETODOLACMedsource Pharmaceuticals12f0685b-2127-d0d6-e063-6394a90a62d12024-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
EtodolacETODOLACProficient Rx LPe2fef939-2f4a-46ae-8177-073f5e8f57f52023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
ndc (product): 63187-736
EtodolacETODOLACA-S Medication Solutions74baa6ad-b517-48e2-8cef-d77f5755b2792023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004
ndc (product): 50090-1790
EtodolacETODOLACProficient Rx LP0c783997-6f2a-45ae-b899-c060c8be468a2022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076004
application number: ANDA076004

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 89 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-578EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-578EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-578EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-578EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-671EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-671EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-671EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-671EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-671EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-856EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-856EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-856EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-856EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-856EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-856EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-856EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1789EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1789EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1789EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1789EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1789EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1789EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1789EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1790EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1790EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1790EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1790EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-2133EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-2133EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-2133EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-2133EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-2133EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-2133EtodolacEtodolacA-S Medication SolutionsANDACurrent
50436-0041EtodolacEtodolacUnit Dose ServicesANDACurrent
53217-362EtodolacEtodolacAidarex Pharmaceuticals LLCANDACurrent
53217-371EtodolacEtodolacAidarex Pharmaceuticals LLCANDACurrent
55700-592EtodolacEtodolacQuality Care Products LLCANDACurrent
55700-592EtodolacEtodolacLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-592EtodolacEtodolacLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-592EtodolacEtodolacLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-592EtodolacEtodolacLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-592EtodolacEtodolacQuality Care Products LLCANDACurrent
55700-592EtodolacEtodolacLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-592EtodolacEtodolacLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-757EtodolacEtodolacQuality Care Products, LLCANDACurrent
55700-757EtodolacEtodolacQuality Care Products, LLCANDACurrent
55700-757EtodolacEtodolacQuality Care Products, LLCANDACurrent
60505-0041EtodolacEtodolacApotex Corp.ANDACurrent
60505-0041EtodolacEtodolacApotex Corp.ANDACurrent
60505-0041EtodolacEtodolacApotex Corp.ANDACurrent
60505-0041EtodolacEtodolacApotex Corp.ANDACurrent
60505-0041EtodolacEtodolacApotex Corp.ANDACurrent
60505-0041EtodolacEtodolacApotex Corp.ANDACurrent
60505-0102EtodolacEtodolacApotex Corp.ANDACurrent
60505-0102EtodolacEtodolacApotex Corp.ANDACurrent
60505-0102EtodolacEtodolacApotex Corp.ANDACurrent
60505-0102EtodolacEtodolacApotex Corp.ANDACurrent
60505-0102EtodolacEtodolacApotex Corp.ANDACurrent
60505-0102EtodolacEtodolacApotex Corp.ANDACurrent
60760-552EtodolacEtodolacSt. MaryANDACurrent
60760-552EtodolacEtodolacSt. MaryANDACurrent
60760-552EtodolacEtodolacSt. MaryANDACurrent
61919-251ETODOLACETODOLACDIRECT RXANDACurrent
61919-251ETODOLACETODOLACDIRECT RXANDACurrent
61919-251ETODOLACETODOLACDIRECT RXANDACurrent
61919-784ETODOLACETODOLACDIRECT RXANDACurrent
61919-784ETODOLACETODOLACDIRECT RXANDACurrent
61919-858ETODOLACETODOLACDIRECT RXANDACurrent
63187-736EtodolacEtodolacProficient Rx LPANDACurrent
63187-736EtodolacEtodolacProficient Rx LPANDACurrent
63187-736EtodolacEtodolacProficient Rx LPANDACurrent
63629-8805EtodolacEtodolacBryant Ranch PrepackANDACurrent
63629-8805EtodolacEtodolacBryant Ranch PrepackANDACurrent
66267-095EtodolacEtodolacNuCare Pharmaceuticals, Inc.ANDACurrent
66267-095EtodolacEtodolacNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6901EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-6901EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-9410EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-9410EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-9410EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent