FDA.reportPublic FDA data

Application 207753

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENCAPSULE;ORALEQ 200MG FREE ACID AND POTASSIUM SALTNoNo

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
A207753-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29

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 UTC2022-10A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENAurohealth LLC43c94480-78d1-4a23-91d4-1d49fea72cb72026-06-05WarningsExact identifier
application applno (ANDA): 207753
application number: ANDA207753
ndc (product): 58602-852
IbuprofenIBUPROFENP & L Development, LLCce215099-91b0-43fd-8ac9-17fe6508842c2025-11-11WarningsExact identifier
application applno (ANDA): 207753
application number: ANDA207753
ndc (product): 59726-046
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)da9d0301-ec14-40c5-b0b9-17096913a8492025-11-11WarningsExact identifier
application applno (ANDA): 207753
application number: ANDA207753
ndc (product): 55910-046
IbuprofenIBUPROFENBetter Living Brands LLCf6ef7f73-b5ab-4c82-e053-6394a90ac81e2023-09-22WarningsExact identifier
application applno (ANDA): 207753
application number: ANDA207753
IbuprofenIBUPROFENRITE AID CORPORATIONde158883-1175-18fc-e053-2995a90a3c962023-04-12WarningsExact identifier
application applno (ANDA): 207753
application number: ANDA207753
ndc (product): 11822-4258
IbuprofenIBUPROFENAurohealth LLCe1b49257-d226-457f-8f2d-9a757a65bbcb2022-09-06WarningsExact identifier
application applno (ANDA): 207753
application number: ANDA207753
ndc (product): 58602-879
IbuprofenIBUPROFENAurohealth LLC7779c369-50bf-4cde-9015-ff3fb35e128e2022-05-16WarningsExact identifier
application applno (ANDA): 207753
application number: ANDA207753
ndc (product): 58602-843
IbuprofenIBUPROFENAurohealth LLC3b0e77a1-b49d-4c67-81dd-66450dabcf3b2022-03-04WarningsExact identifier
application applno (ANDA): 207753
application number: ANDA207753
ndc (product): 58602-902

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 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11822-4258IbuprofenIbuprofenRITE AID CORPORATIONANDACurrent
55319-046IbuprofenIbuprofenFamily Dollar (FAMILY WELLNESS)ANDACurrent
55319-046IbuprofenIbuprofenFamily Dollar (FAMILY WELLNESS)ANDACurrent
55910-046IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-046IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
58602-843IbuprofenIbuprofenAurohealth LLCANDACurrent
58602-843IbuprofenIbuprofenAurohealth LLCANDACurrent
58602-843IbuprofenIbuprofenAurohealth LLCANDACurrent
58602-852IbuprofenIbuprofenAurohealth LLCANDACurrent
58602-879IbuprofenIbuprofenAurohealth LLCANDACurrent
58602-902IbuprofenIbuprofenAurohealth LLCANDACurrent
58602-902IbuprofenIbuprofenAurohealth LLCANDACurrent
58602-902IbuprofenIbuprofenAurohealth LLCANDACurrent
58602-902IbuprofenIbuprofenAurohealth LLCANDACurrent
58602-902IbuprofenIbuprofenAurohealth LLCANDACurrent
59726-046IbuprofenIbuprofenP & L Development, LLCANDACurrent
59726-046IbuprofenIbuprofenP & L Development, LLCANDACurrent
59726-046IbuprofenIbuprofenP & L Development, LLCANDACurrent
59726-046IbuprofenIbuprofenP & L Development, LLCANDACurrent