Application 090796

Type
ANDA
Sponsor
MARKSANS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL400MGNoNo
002IBUPROFENIBUPROFENTABLET;ORAL600MGNoNo
003IBUPROFENIBUPROFENTABLET;ORAL800MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090796-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2010-12-21
A090796-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2010-12-21
A090796-003IBUPROFENIBUPROFEN800MGTABLET / ORALAB2010-12-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090796-001AB
A090796-002AB
A090796-003AB

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 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-2184e616aacf4f…
2026-09-14 22:38:342026-08A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-2184e616aacf4f…
2026-09-14 22:38:342026-08A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-2184e616aacf4f…
2026-08-18 06:07:402026-07A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090796-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090796-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090796-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A090796-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090796-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090796-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090796-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090796-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090796-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090796-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090796-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090796-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090796-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090796-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090796-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090796-001AB1301d65b070ca…

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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENREMEDYREPACK INC.a7756b22-73cf-4262-aa8e-0577ddecd03b2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
ndc (product): 70518-2432
IBUPROFENIBUPROFENSt. Mary's Medical Park Pharmacy950c3ca7-4481-976f-e053-2995a90ad51e2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IBUPROFENIBUPROFENSt. Mary's Medical Park Pharmacy95830141-2439-9d45-e053-2995a90ae0842026-05-01Exact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENREMEDYREPACK INC.a348a959-46bc-4ff6-8936-12866fc34a4b2026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
ndc (product): 70518-3313
IbuprofenIBUPROFENNorthwind Health Company, LLCc20f1f4d-59b3-6bbe-e053-2a95a90abaf12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENNorthwind Health Company, LLCdac07d8f-6b6f-20ab-e053-2a95a90af3ba2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENNorthwind Health Company, LLCda6c72ad-009f-3d7f-e053-2995a90a68e92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENQPharma, Inc.f452d2c3-525f-4933-b146-92351d0ae44f2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.ce5b0429-bbe1-47a4-af5e-0159d3cfd2c32025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IBUPROFENIBUPROFENDirect Rxd88d0544-57a7-4a82-e053-2a95a90a19452025-01-21Exact identifier
application applno (ANDA): 090796
application number: ANDA090796
ndc (product): 72189-324
IBUPROFENIBUPROFENDIRECT RXc3f30813-0848-6e8a-e053-2995a90a3dea2025-01-20Exact identifier
application applno (ANDA): 090796
application number: ANDA090796
ndc (product): 72189-266
ndc (product): 72189-231
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.7546e868-d99f-4f8c-b1e9-cc96fd9fa1eb2025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.701ee488-c57f-a82c-e053-2991aa0af4032025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.9b02607a-6fab-5205-e053-2a95a90afa262025-01-02Exact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCb33caad1-8d40-16f2-e053-2a95a90a1b2d2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
ndc (product): 80425-0089
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCbd1ca7af-d640-23fb-e053-2a95a90a8a982024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
ndc (product): 80425-0132
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCf18b6a0a-e42f-083d-e053-2995a90a40e42024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
ndc (product): 80425-0243
IbuprofenIBUPROFENTIME CAP LABORATORIES, INCec3e8443-d742-4c25-8516-f0df4ebfccdc2024-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENMARKSANS PHARMA LIMITEDe54209c2-f726-440b-ac60-5a72710d2a9b2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC19b06eaf-0d4c-2b4d-e063-6294a90a2eb92024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796

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 3 of 3 · 210 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70518-0005IBUPROFENIBUPROFENREMEDYREPACK INC.ANDACurrent
70518-0098ibuprofenibuprofenREMEDYREPACK INC.ANDACurrent
70518-2432IBUPROFENIBUPROFENREMEDYREPACK INC.ANDACurrent
70518-2432IBUPROFENIBUPROFENREMEDYREPACK INC.ANDACurrent
70518-3313IBUPROFENIBUPROFENREMEDYREPACK INC.ANDACurrent
70934-051IBUPROFENIBUPROFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-051IBUPROFENIBUPROFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-051IBUPROFENIBUPROFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-051IBUPROFENIBUPROFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-051IBUPROFENIBUPROFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-051IBUPROFENIBUPROFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-051IBUPROFENIBUPROFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-375IBUPROFENIBUPROFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-375IBUPROFENIBUPROFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-375IBUPROFENIBUPROFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-375IBUPROFENIBUPROFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-375IBUPROFENIBUPROFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-509IBUPROFENIBUPROFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-1396IBUPROFENIBUPROFENBryant Ranch PrepackANDACurrent
71335-1396IBUPROFENIBUPROFENBryant Ranch PrepackANDACurrent
71335-1503IBUPROFENIBUPROFENBryant Ranch PrepackANDACurrent
71335-1517IBUPROFENIBUPROFENBryant Ranch PrepackANDACurrent
71610-387IBUPROFENIBUPROFENAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-532IBUPROFENIBUPROFENAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-231IBUPROFENIBUPROFENDIRECT RXANDACurrent
72189-231IBUPROFENIBUPROFENDIRECT RXANDACurrent
72189-231IBUPROFENIBUPROFENDIRECT RXANDACurrent
72189-231IBUPROFENIBUPROFENDIRECT RXANDACurrent
72189-231IBUPROFENIBUPROFENDIRECT RXANDACurrent
72189-231IBUPROFENIBUPROFENDIRECT RXANDACurrent
72189-231IBUPROFENIBUPROFENDIRECT RXANDACurrent
72189-231IBUPROFENIBUPROFENDIRECT RXANDACurrent
72189-266IBUPROFENIBUPROFENDIRECT RXANDACurrent
72189-266IBUPROFENIBUPROFENDIRECT RXANDACurrent
72189-266IBUPROFENIBUPROFENDIRECT RXANDACurrent
72189-266IBUPROFENIBUPROFENDIRECT RXANDACurrent
72189-266IBUPROFENIBUPROFENDIRECT RXANDACurrent
72189-266IBUPROFENIBUPROFENDIRECT RXANDACurrent
72189-324IBUPROFENIBUPROFENDirect RxANDACurrent
72189-324IBUPROFENIBUPROFENDirect RxANDACurrent
72189-324IBUPROFENIBUPROFENDirect RxANDACurrent
80425-0089MotrinIbuprofen 800mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0089IbuprofenIbuprofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0089IbuprofenIbuprofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0089IbuprofenIbuprofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0132IbuprofenIbuprofen 600mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0132IbuprofenIbuprofen 600mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0132IbuprofenIbuprofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0132IbuprofenIbuprofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0243IbuprofenIbuprofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent