FDA.reportPublic FDA data

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 44.

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15c2088c7a36db…
2026-10-15 13:18:302026-09A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15c2088c7a36db…
2026-10-15 13:18:302026-09A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15c2088c7a36db…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A091625-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A091625-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A091625-003AB1c2088c7a36db…
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…

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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENNorthwind Health Company, LLC2f12a20c-4293-d18a-e063-6294a90a3afc2026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENNorthwind Health Company, LLCf2a08223-a73a-5461-e053-2995a90a3bce2025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENNorthwind Health Company, LLCab074ae8-5696-5327-e053-2a95a90a7ce32025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENBryant Ranch Prepack894a5d14-e405-43ac-a5a2-0b4de5b284742025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCaf9ac948-440c-5abf-e053-2995a90af2b52025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCc859cc7a-e13a-7df4-e053-2a95a90a47d62024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENBryant Ranch Prepackd0198bdc-fe2b-4b09-8f78-9e5a7f6ae7842024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENBryant Ranch Prepack60f1c099-5fb5-47e8-b228-11de1ef40f4b2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENBryant Ranch Prepackffc953f7-ed92-4528-bb2f-72c634c119fa2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENEXELAN PHARMACEUTICALS, INC.362f934a-4382-43bc-bedd-65081286f1c92024-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENA-S Medication Solutionsfd691a4a-8010-45e6-b3da-b26374792f242024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENA-S Medication Solutions8553e29a-7f6f-4ff8-9991-836e619c504d2023-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENA-S Medication Solutionse4644cb5-7fae-456a-98d3-62ba521cd0b22023-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENPharmPak, Inc.b493bf76-1e8b-4e72-bef6-aca4efc69cbe2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENPharmPak, Inc.4d95bccd-8280-4d03-a574-927669c7cda02022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENPharmPak, Inc.bb6d0547-c113-42f9-8bf2-c227a55ab7582022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENProficient Rx LPd2c7f045-e70c-4e2b-b2e0-d81a271d0a042022-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
ndc (product): 63187-980
IbuprofenIBUPROFENProficient Rx LP2dc3108f-d917-40c6-865d-c900cf055d1c2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
ndc (product): 63187-992
IbuprofenIBUPROFENProficient Rx LP444b2ea0-ec42-4bcf-b8d2-38b4b297ada02022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
ndc (product): 63187-967
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC4a86a190-da5d-4b7a-a05f-e3e7ccbfa6032019-01-19Boxed 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 2 of 4 · 293 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62207-354IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-354IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-354IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-354IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-354IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-354IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-354IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-354IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-354IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-354IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-354IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-354IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-355IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-355IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-355IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-355IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-355IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-355IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-355IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-355IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-355IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-355IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-355IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-355IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-355IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-356IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-356IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-356IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-356IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-356IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-356IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-356IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-356IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-356IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-356IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-356IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-356IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-356IbuprofenIbuprofenGranules India LimitedANDACurrent
63187-967IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-967IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-967IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-967IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-980IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-980IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-980IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-980IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-980IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-980IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-980IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-992IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-992IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-992IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-992IbuprofenIbuprofenProficient Rx LPANDACurrent
63187-992IbuprofenIbuprofenProficient Rx LPANDACurrent
63629-7676IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
63629-7676IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
63629-7676IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
63629-7676IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
63629-7964IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
63629-7964IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
67046-301IbuprofenIbuprofenContract Pharmacy Services-PAANDACurrent
67046-315IbuprofenIbuprofenContract Pharmacy Services-PAANDACurrent
67296-1581IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1581IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1588IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1588IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1588IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1611IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1611IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1611IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67877-319IbuprofenIbuprofenAscend Laboratories, LLCANDACurrent
67877-319IbuprofenIbuprofenAscend Laboratories, LLCANDACurrent
67877-319IbuprofenIbuprofenAscend Laboratories, LLCANDACurrent
67877-320IbuprofenIbuprofenAscend Laboratories, LLCANDACurrent
67877-320IbuprofenIbuprofenAscend Laboratories, LLCANDACurrent
67877-320IbuprofenIbuprofenAscend Laboratories, LLCANDACurrent
67877-321IbuprofenIbuprofenAscend Laboratories, LLCANDACurrent
67877-321IbuprofenIbuprofenAscend Laboratories, LLCANDACurrent
67877-321IbuprofenIbuprofenAscend Laboratories, LLCANDACurrent
68071-3388IbuprofenIbuprofenNuCare Pharmaceuticals, Inc.ANDACurrent