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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15a50c72e98297…
2026-08-01 22:54:322026-06A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15a50c72e98297…
2026-08-01 22:54:322026-06A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091625-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091625-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A091625-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
ndc (product): 50090-2626
IbuprofenIBUPROFENA-S Medication Solutions51de1183-d226-4869-a00a-f6c74e126a392026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
ndc (product): 50090-2548
ndc (product): 50090-2996
ndc (product): 50090-2629
IbuprofenIBUPROFENA-S Medication Solutions25a94943-9acc-49c8-a4da-7e07bb2c35eb2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
ndc (product): 50090-2625
IbuprofenIBUPROFENNorthwind Health Company, LLCab80abe6-f7db-479b-e053-2a95a90a90e32026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
ndc (product): 51655-385
IbuprofenIBUPROFENAscend Laboratories, LLC9ce036ef-a22d-4fca-9a62-1b10978f7b262026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.560e4e05-21e0-4b2a-ab2f-872b5dbb39012026-05-22Boxed 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
ndc (product): 61919-463
IbuprofenIBUPROFENLegacy Pharmaceutical Packaging, LLC5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625

NDC Listings For This Application#

NDC listings for this application page 1 of 4 · 293 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42708-006IbuprofenIbuprofenQPharma IncANDACurrent
42708-006IbuprofenIbuprofenQPharma IncANDACurrent
42708-006IbuprofenIbuprofenQPharma IncANDACurrent
42708-121IbuprofenIbuprofenQPharma IncANDACurrent
42708-121IbuprofenIbuprofenQPharma IncANDACurrent
42708-121IbuprofenIbuprofenQPharma IncANDACurrent
50090-2548IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2548IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2548IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2548IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2548IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2549IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2549IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2549IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2549IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2597IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2597IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2597IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2625IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2625IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2625IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2626IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2626IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2626IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2629IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2629IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2670IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2996IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-3007IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-3007IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-3007IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50436-0319IbuprofenIbuprofenUnit Dose ServicesANDACurrent
50436-0319IbuprofenIbuprofenUnit Dose ServicesANDACurrent
50436-0321IbuprofenIbuprofenUnit Dose ServicesANDACurrent
50436-0321IbuprofenIbuprofenUnit Dose ServicesANDACurrent
50436-3200IbuprofenIbuprofenUnit Dose ServicesANDACurrent
50436-3200IbuprofenIbuprofenUnit Dose ServicesANDACurrent
51655-048IbuprofenIbuprofenNorthwind PharmaceuticalsANDACurrent
51655-048IbuprofenIbuprofenNorthwind PharmaceuticalsANDACurrent
51655-385IbuprofenIbuprofenNorthwind PharmaceuticalsANDACurrent
51655-385IbuprofenIbuprofenNorthwind PharmaceuticalsANDACurrent
53217-364IbuprofenIbuprofenAidarex Pharmaceuticals LLCANDACurrent
54348-825IbuprofenIBUPROFENPharmPak, Inc.ANDACurrent
54348-825IbuprofenIBUPROFENPharmPak, Inc.ANDACurrent
54348-830IbuprofenIBUPROFENPharmPak, Inc.ANDACurrent
54348-830IbuprofenIBUPROFENPharmPak, Inc.ANDACurrent
54348-835IbuprofenIBUPROFENPharmPak, Inc.ANDACurrent
54348-835IbuprofenIBUPROFENPharmPak, Inc.ANDACurrent
55700-445IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-445IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-445IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-445IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-445IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-445IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-446IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-446IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-446IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-446IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-446IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-446IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-694IbuprofenIbuprofenQuality Care Products, LLCANDACurrent
55700-694IbuprofenIbuprofenQuality Care Products, LLCANDACurrent
55700-694IbuprofenIbuprofenQuality Care Products, LLCANDACurrent
55700-694IbuprofenIbuprofenQuality Care Products, LLCANDACurrent
59088-756IBUPAKIbuprofenPureTek CorporationANDACurrent
60760-374IbuprofenIbuprofenSt. Mary's Medical Park PharmacyANDACurrent
60760-375IbuprofenIbuprofenSt. Mary's Medical Park PharmacyANDACurrent
61919-463IBUPROFENIBUOROFENDIRECT RXANDACurrent
61919-463IBUPROFENIBUOROFENDIRECT RXANDACurrent
61919-463IBUPROFENIBUOROFENDirect_RxANDACurrent
61919-463IBUPROFENIBUOROFENDirect_RxANDACurrent
61919-463IBUPROFENIBUOROFENDirect_RxANDACurrent
61919-628IBUPROFENIBUPROFENDIRECT RXANDACurrent
61919-628IBUPROFENIBUPROFENDirect_RxANDACurrent
61919-628IBUPROFENIBUPROFENDirect_RxANDACurrent
61919-628IBUPROFENIBUPROFENDirect_RxANDACurrent
61919-683IBUPROFENIBUPROFENDirect_RxANDACurrent
61919-683IBUPROFENIBUPROFENDirect_RxANDACurrent
61919-683IBUPROFENIBUPROFENDirect_RxANDACurrent
62207-354IbuprofenIbuprofenGranules India LimitedANDACurrent