FDA.reportPublic FDA data

Application 079205

Type
ANDA
Sponsor
MARKSANS PHARMA

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 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
A079205-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26

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 UTC2022-09A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26a50c72e98297…

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENGOODSENSE596a1007-08ea-00ec-e063-6394a90a5eb22026-09-09WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENHarris Teeter87ffbf01-54de-45a8-b2a3-367d219278822026-07-29WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
ndc (product): 72036-185
Ibuprofen MinisIBUPROFENGrocery Outlet, Inc.44665e3d-37a7-a1a7-e063-6294a90ab3762026-03-04WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENWALGREENS40a1e525-fb1e-08f4-e063-6294a90adfa72026-01-14WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IBUPROFENIBUPROFENTIME CAP LABORATORIES, INCe0a8315a-80a5-4be3-aad1-3d01f00df4942025-12-29WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
ndc (product): 49483-610
IbuprofenIBUPROFENAMERIFOODS TRADING COMPANY3802ebc9-83ca-602a-e063-6294a90a11c82025-11-20WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENBJWC (Berkley & Jensen / BJ's)2f322afb-bfc8-9dab-e063-6394a90a08b52025-08-19WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENFSA STORE INC.ec6b1b86-46fc-7e82-e053-2a95a90ac1472025-08-12WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
ndc (product): 81522-185
IbuprofenIBUPROFENMARC GLASSMAN, INC.7f366669-9d31-46c7-932d-02fa64b11f302025-07-15WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
ndc (product): 68998-185
IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI37eaa3b1-98e9-4fcf-ae74-153bfc35551f2025-07-01WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
ndc (product): 41163-185
IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLC2810122e-3c89-49a2-8dac-db3714cb7b452024-12-30WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
ndc (product): 68210-0200
IbuprofenIBUPROFENWinco Foods, LLC61cd9140-eded-4bcf-894b-a163fa5f3e102024-12-06WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
ndc (product): 67091-185
PROPRINALIBUPROFEN CAPSULES 200 MGHART Healthec27b625-a3fa-4c5f-8134-c9373c09b3e32024-12-04WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb619068-be71-7569-e053-2a95a90a4a6e2024-10-26WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IBUPROFENIBUPROFENKroger Companybc178013-ab2e-04f5-e053-2995a90a1ed42024-04-13WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
ndc (product): 41226-610
IbuprofenIBUPROFENKROGER COMPANY0fbe42d0-b5f0-0780-e063-6394a90a4ecb2024-04-13WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IBUPROFENIBUPROFENWALGREENS3ce5b71b-f841-444f-bf66-023e4bd9aa162024-03-15WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
ndc (product): 0363-1610
PROPRINALIBUPROFEN CAPSULES 200 MGA-S Medication Solutions4723dd14-5d20-4a9a-b127-4237d5db59562024-01-29WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IBUPROFENIBUPROFENTARGET CORPORATION8e8646fe-fd62-1662-e053-2a95a90a30082024-01-03WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
ndc (product): 11673-992
Ibuprofen MiniIBUPROFEN MINI 200 MGTARGET CORPORATIONc80426d9-e121-c24d-e053-2a95a90acf2f2024-01-03WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
ndc (product): 11673-683

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 · 59 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0003IBUPROFENibuprofenWalgreen CompanyANDACurrent
0363-1610IBUPROFENIBUPROFENWALGREENSANDACurrent
0363-1610IBUPROFENIBUPROFENWALGREENSANDACurrent
0363-1610IBUPROFENIBUPROFENWALGREENSANDACurrent
11673-683Ibuprofen MiniIbuprofen Mini 200 mgTARGET CORPORATIONANDACurrent
11673-992IBUPROFENIBUPROFENTARGET CORPORATIONANDACurrent
11673-992IBUPROFENIBUPROFENTARGET CORPORATIONANDACurrent
11673-992IBUPROFENIBUPROFENTARGET CORPORATIONANDACurrent
11673-992IBUPROFENIBUPROFENTARGET CORPORATIONANDACurrent
25000-062IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-062IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-133IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-133IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-133IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-133IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-133IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
41163-185IbuprofenIbuprofenSuperValu Inc.ANDACurrent
41226-610IBUPROFENIBUPROFENKroger CompanyANDACurrent
49035-133Equate IbuprofenIbuprofenWalmart stores IncANDACurrent
49483-133IbuprofenIbuprofen Capsules 200 mgTIME CAP LABORATORIES, INC.ANDACurrent
49483-133IbuprofenIbuprofen Capsules 200 mgTIME CAP LABORATORIES, INC.ANDACurrent
49483-610IBUPROFENIBUPROFENTIME CAP LABORATORIES, INCANDACurrent
49483-610IBUPROFENIBUPROFENTIME CAP LABORATORIES, INCANDACurrent
49483-610IBUPROFENIBUPROFENTIME CAP LABORATORIES, INCANDACurrent
50844-268IbuprofenIbuprofenL.N.K. International, Inc.ANDACurrent
50844-268IbuprofenIbuprofenL.N.K. International, Inc.ANDACurrent
50844-268IbuprofenIbuprofenL.N.K. International, Inc.ANDACurrent
50844-268IbuprofenIbuprofenL.N.K. International, Inc.ANDACurrent
55315-940IBUPROFENIBUPROFENFRED'S INC.ANDACurrent
55315-940IBUPROFENIBUPROFENFRED'S INC.ANDACurrent
55910-399IbuprofenIbuprofenDOLGENCORP, INC.ANDACurrent
57344-185IbuprofenIbuprofenAAA Pharmaceutical, Inc.ANDACurrent
59105-002IBUPROFENIBUPROFENJ.P BUSINESS ENTERPRISEANDACurrent
59779-131CVS Pharmacy IbuprofenIbuprofenCVS PharmacyANDACurrent
63654-363IbuprofenIbuprofen 200 mgSelder, S.A. de C.V.ANDACurrent
67091-185IbuprofenIbuprofenWinco Foods, LLCANDACurrent
67091-185IbuprofenIbuprofenWinco Foods, LLCANDACurrent
68210-0009IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-0009IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-0009IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-0009IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-0009IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-0200IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-0200IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-0200IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-0200IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-0200IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-4141IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-4141IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-4141IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLCANDACurrent
68998-185IbuprofenIbuprofenMARC GLASSMAN, INC.ANDACurrent
69168-363IbuprofenIbuprofen 200 mgAllegiant HealthANDACurrent
69168-368Ibuprofen 200 mgIbuprofenAllegiant HealthANDACurrent
69168-368Ibuprofen 200 mgIbuprofenAllegiant HealthANDACurrent
69168-914Sound Body IbuprofenIbuprofen 200 mgAllegiant HealthANDACurrent
69168-914Sound Body IbuprofenIbuprofen 200 mgAllegiant HealthANDACurrent
69168-914Sound Body IbuprofenIbuprofen 200 mgAllegiant HealthANDACurrent
72036-185IbuprofenIbuprofenHarris TeeterANDACurrent
81522-185IbuprofenIbuprofenFSA STORE INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22635ORIG2011-09-19