FDA.reportPublic FDA data

Application 091355

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL200MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091355-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-04-04

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen Immediate ReleaseIBUPROFENStrides Pharma Incebcc4da3-d0f6-4e40-99b5-e88310ea4a5b2026-09-02Boxed warning, WarningsExact identifier
application applno (ANDA): 091355
application number: ANDA091355
ndc (product): 59556-856
ndc (product): 59556-855
IbuprofenIBUPROFENPioneer Life Sciences, LLC291602fa-8ebe-4200-bba7-9798c90f8a502026-08-03WarningsExact identifier
application applno (ANDA): 091355
application number: ANDA091355
IbuprofenIBUPROFENNUVICARE LLCb063d2dc-d579-46e7-8cfc-1596c803c7f92026-08-03WarningsExact identifier
application applno (ANDA): 091355
application number: ANDA091355

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 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
41163-212IbuprofenIbuprofenSUPERVALU INC.ANDACurrent
41163-711IbuprofenIbuprofenSUPERVALU INC.ANDACurrent
49738-112IbuprofenIbuprofenSMART SENSE (KMART)ANDACurrent
49738-510IbuprofenIbuprofenSMART SENSE (KMART)ANDACurrent
49738-510IbuprofenIbuprofenSMART SENSE (KMART)ANDACurrent
57344-111IbuprofenIbuprofenAAA Pharmaceutical, Inc.ANDACurrent
57344-111IbuprofenIbuprofenAAA Pharmaceutical, Inc.ANDACurrent
57344-112IbuprofenIbuprofenAAA Pharmaceutical, Inc.ANDACurrent
57344-112IbuprofenIbuprofenAAA Pharmaceutical, Inc.ANDACurrent
57910-400IbuprofenIbuprofenShasun Pharmaceuticals LimitedANDACurrent
57910-402IbuprofenIbuprofenShasun Pharmaceuticals LimitedANDACurrent
59556-855IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
59556-855IbuprofenIbuprofenStrides Pharma IncANDACurrent
59556-856IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
59556-856IbuprofenIbuprofenStrides Pharma IncANDACurrent
61715-018IbuprofenIbuprofenKinrayANDACurrent
63868-790Ibuprofen IBIbuprofenChain Drug Marketing AssociationANDACurrent
63868-790Ibuprofen IBIbuprofenChain Drug Marketing AssociationANDACurrent
63868-791Ibuprofen IBIbuprofenChain Drug Marketing AssociationANDACurrent
63868-791Ibuprofen IBIbuprofenChain Drug Marketing AssociationANDACurrent
63868-793Ibuprofen IBIbuprofenChain Drug Marketing AssociationANDACurrent
63868-793Ibuprofen IBIbuprofenChain Drug Marketing AssociationANDACurrent
63868-794Ibuprofen IBIbuprofenChain Drug Marketing AssociationANDACurrent
63868-794Ibuprofen IBIbuprofenChain Drug Marketing AssociationANDACurrent
67091-129Ibuprofen IBIbuprofenWinCo Foods, LLCANDACurrent
67091-129Ibuprofen IBIbuprofenWinCo Foods, LLCANDACurrent
67091-130Ibuprofen IBIbuprofenWinCo Foods, LLCANDACurrent
67091-130Ibuprofen IBIbuprofenWinCo Foods, LLCANDACurrent
68210-4200IbuprofenIbuprofenSpirit Pharmaceuticals LLCANDACurrent
68210-4200IbuprofenIbuprofenSpirit Pharmaceuticals LLCANDACurrent
68998-111IbuprofenIbuprofenMarc Glassman, Inc.ANDACurrent
68998-111IbuprofenIbuprofenMarc Glassman, Inc.ANDACurrent
68998-112IbuprofenIbuprofenMarc Glassman, Inc.ANDACurrent
68998-112IbuprofenIbuprofenMarc Glassman, Inc.ANDACurrent
69168-338IbuprofenIbuprofen 200 mgAllegiant HealthANDACurrent
72036-111IbuprofenIbuprofenHarris TeeterANDACurrent
72036-112IbuprofenIbuprofenHarris TeeterANDACurrent