Application 091625

Type
ANDA
Sponsor
GRANULES INDIA LTD

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
A091625-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2015-09-15
A091625-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2015-09-15
A091625-003IBUPROFENIBUPROFEN800MGTABLET / ORALAB2015-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091625-001AB
A091625-002AB
A091625-003AB

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 22:38:342026-08A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-1584e616aacf4f…
2026-09-14 22:38:342026-08A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-1584e616aacf4f…
2026-09-14 22:38:342026-08A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-1584e616aacf4f…
2026-08-18 06:07:402026-07A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15301d65b070ca…

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 22:38:342026-08A091625-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A091625-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A091625-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A091625-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091625-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091625-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091625-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091625-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091625-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091625-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091625-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091625-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091625-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091625-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091625-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091625-001AB1301d65b070ca…

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENREMEDYREPACK INC.560e4e05-21e0-4b2a-ab2f-872b5dbb39012026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
ndc (product): 70518-3178
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.d3a7ebef-f7ab-4b34-b62e-278a8deabf782026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.b81c6495-8b30-41ef-8a0f-4cbfd87f1eb42026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d82026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.57a1bf99-5aaf-432d-86ba-5f0e7cfab1a02026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENBryant Ranch Prepackf1c88d74-09b0-4b14-baea-106fbbbc54bf2026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.b6a6c940-daf6-4e0e-aefb-35cce87a9a552026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.421156d2-85dc-4680-b2b4-d15b67539e872026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
ndc (product): 70518-1409
IbuprofenIBUPROFENREMEDYREPACK INC.20078671-536f-4b0b-a079-f90ac186a6702026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.1e6f3ce7-e8a3-40e8-8437-523ef5277b2e2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENUnit Dose Solutions, Inc.5515661b-6373-2191-e063-6294a90a17e02026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENA-S Medication Solutionsb40f39e4-a37c-4039-ae37-210c1c3c62352026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENA-S Medication Solutions51de1183-d226-4869-a00a-f6c74e126a392026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENA-S Medication Solutions25a94943-9acc-49c8-a4da-7e07bb2c35eb2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENNorthwind Health Company, LLCab80abe6-f7db-479b-e053-2a95a90a90e32026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENAscend Laboratories, LLC9ce036ef-a22d-4fca-9a62-1b10978f7b262026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENQPharma Incfd8b82a7-96fe-8bf5-e053-6394a90a39352026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENGranules Pharmaceuticals Inc.4aefcb3a-5dc8-b88e-e063-6294a90ac0442026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IBUPROFENIBUOROFENDirect_Rx90b8b80e-ab30-3590-e053-2a95a90a70ef2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENLegacy Pharmaceutical Packaging, LLC5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625

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 4 of 4 · 293 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70518-1409IbuprofenIbuprofenREMEDYREPACK INC.ANDACurrent
70518-3178IbuprofenIbuprofenREMEDYREPACK INC.ANDACurrent
70518-3178IbuprofenIbuprofenREMEDYREPACK INC.ANDACurrent
70518-3178IbuprofenIbuprofenREMEDYREPACK INC.ANDACurrent
70518-3178IbuprofenIbuprofenREMEDYREPACK INC.ANDACurrent
70518-3178IbuprofenIbuprofenREMEDYREPACK INC.ANDACurrent
70518-3178IbuprofenIbuprofenREMEDYREPACK INC.ANDACurrent
70934-032IbuprofenIbuprofenDenton Pharma, Inc.ANDACurrent
70934-032IbuprofenIbuprofenDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-032IbuprofenIbuprofenDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-032IbuprofenIbuprofenDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-080IbuprofenIbuprofenDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-080IbuprofenIbuprofenDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-080IbuprofenIbuprofenDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-080IbuprofenIbuprofenDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-130IbuprofenIbuprofenDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-130IbuprofenIbuprofenDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-130IbuprofenIbuprofenDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-130IbuprofenIbuprofenDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0690IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-0690IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-0690IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-0690IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-1073IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-1073IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-1218IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-1218IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-1218IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-1564IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-1564IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
71550-100IbuprofenIbuprofenVirtue Rx, LLCANDACurrent
71610-202IbuprofenIbuprofenAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-222IbuprofenIbuprofenAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-644IbuprofenIbuprofenAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-645IbuprofenIbuprofenAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-646IbuprofenIbuprofenAphena Pharma Solutions - Tennessee, LLCANDACurrent
76282-712IbuprofenIbuprofenEXELAN PHARMACEUTICALS, INC.ANDACurrent
76282-712IbuprofenIbuprofenEXELAN PHARMACEUTICALS, INC.ANDACurrent
76282-713IbuprofenIbuprofenEXELAN PHARMACEUTICALS, INC.ANDACurrent
76282-713IbuprofenIbuprofenEXELAN PHARMACEUTICALS, INC.ANDACurrent
76282-714IbuprofenIbuprofenEXELAN PHARMACEUTICALS, INC.ANDACurrent
76282-714IbuprofenIbuprofenEXELAN PHARMACEUTICALS, INC.ANDACurrent
80175-0321IbuprofenIbuprofenCentral PackagingANDACurrent
80175-0321IbuprofenIbuprofenCentral PackagingANDACurrent
80425-0046MotrinIbuprofen 800mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0046MotrinIbuprofen 800mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0046IbuprofenIbuprofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0046IbuprofenIbuprofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0046IbuprofenIbuprofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0046IbuprofenIbuprofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0154MotrinIbuprofen 600mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0154IbuprofenIbuprofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0154IbuprofenIbuprofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent