FDA.reportPublic FDA data

Application 079058

Type
ANDA
Sponsor
TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENSUSPENSION/DROPS;ORAL40MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A079058-001IBUPROFENIBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Infants IbuprofenIBUPROFENWalgreens3bbbe142-a00c-404b-a116-81ad730ea1302026-08-25WarningsExact identifier
application applno (ANDA): 079058
application number: ANDA079058
ndc (product): 0363-5100

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-1252Infants IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1252Infants IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-5100Infants IbuprofenIbuprofenWalgreensANDACurrent
0363-5100Infants IbuprofenIbuprofenWalgreensANDACurrent
0363-5100Infants IbuprofenIbuprofenWalgreensANDACurrent
11822-1250Infants IbuprofenIbuprofenRite AidANDACurrent
45963-125Infants IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
49035-125Infants IbuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-125Infants IbuprofenIbuprofenWal-Mart Stores IncANDACurrent
55319-250Infants IbuprofenIbuprofenFamily Dollar Services Inc.ANDACurrent
59779-925Infants IbuprofenIbuprofenCVS PharmacyANDACurrent
63029-900PediaCare InfantsIbuprofenMedtech Products Inc.ANDACurrent
63868-076Infants IbuprofenIbuprofenChain Drug Marketing Association Inc.ANDACurrent
63941-125Infants IbuprofenIbuprofenBest Choice (Valu Merchandisers Company)ANDACurrent
63941-125Infants IbuprofenIbuprofenValu Merchandisers CompanyANDACurrent
68016-125Infants IbuprofenIbuprofenChain Drug Consortium, LLCANDACurrent
71205-110Infants IbuprofenIbuprofenProficient Rx LPANDACurrent
71205-110Infants IbuprofenIbuprofenProficient Rx LPANDACurrent