FDA.reportPublic FDA data

Application 078682

Type
ANDA
Sponsor
BIONPHARMA INC

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
A078682-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24

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 UTC2022-10A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24a50c72e98297…

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 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENGobrands, Inc. (Goodnow)04e1b176-b74a-413e-a8e1-dd3764b9aa8b2026-09-01WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENSafeway, Inc.57f06daf-690d-44a7-95a5-4687329497502026-08-19WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
ndc (product): 21130-699
Ibuprofen mini dye freeIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.552d9018-cc7e-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)fb842f4d-1228-9a52-e053-6294a90adb412026-06-26WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
Ibuprofen Mini Dye FreeIBUPROFENCVS Pharmacy42c7dbec-2e53-70ae-e063-6294a90a16e62026-06-25WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)c62cc12f-5a0e-389a-e053-2995a90a208c2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
ndc (product): 36800-221
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)c6297c23-3b27-c0c6-e053-2995a90a3e762026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
ndc (product): 36800-193
IbuprofenIBUPROFENMEIJER DISTRIBUTION INC.a139e495-3dbf-4998-e053-2a95a90ac1362026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
pain reliefIBUPROFENBionpharma Inc.a14ca126-fada-c903-e053-2995a90ae72d2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENHEBca4be24c-5d92-ddc9-e053-2a95a90aa5a72026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
ndc (product): 37808-609
IbuprofenIBUPROFENDOLGENCORP INC03138a6f-653a-f359-e063-6394a90ac5d62026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFEN CAPSULEPUBLIX SUPER MARKETS INC10a6eba7-e400-ce97-e063-6294a90af3bd2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IBUPROFENIBUPROFENDISCOUNT DRUG MART, INC.d07ea9e3-88b0-4aa0-903a-10555dcca37d2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENDISCOUNT DRUG MART, INC.aae40114-343e-12da-e053-2a95a90a92132026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENBJWC0ca0b6cf-7d1f-4673-b9b9-48f78d80c00a2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
pain reliefIBUPROFENBionpharma Inc.2b4ecdd8-627a-445f-8ddc-f2b6c832c1e82026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
dye-free pain reliefIBUPROFENBionpharma Inc.c46c9c36-8844-7b50-e053-2a95a90aa0e92026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
dye-free pain reliefIBUPROFENBionpharma Inc.4227d0b7-846a-dcb0-e063-6294a90af7d72026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.3c1c1b65-f57f-62b0-e063-6294a90a10212026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.3802982a-2373-9ca3-e063-6394a90a0ab72026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682

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 3 · 239 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0103Dye-Free Ibuprofen 200IbuprofenWALGREEN COMPANYANDACurrent
0363-0103Dye-Free Ibuprofen 200IbuprofenWALGREEN COMPANYANDACurrent
0363-0103Dye-Free Ibuprofen 200IbuprofenWALGREEN COMPANYANDACurrent
0363-0197IbuprofenIbuprofenWalgreensANDACurrent
0363-0197IbuprofenIbuprofenWalgreensANDACurrent
0363-0221IbuprofenIbuprofenWALGREEN COMPANYANDACurrent
0363-0221IbuprofenIbuprofenWALGREEN COMPANYANDACurrent
0363-0221IbuprofenIbuprofenWALGREEN COMPANYANDACurrent
0363-0222Ibuprofen 200IbuprofenWALGREEN COMPANYANDACurrent
0363-0225Dye-Free Ibuprofen 200IbuprofenWALGREEN COMPANYANDACurrent
0363-0225Dye-Free Ibuprofen 200IbuprofenWALGREEN COMPANYANDACurrent
0363-0225Dye-Free Ibuprofen 200IbuprofenWALGREEN COMPANYANDACurrent
0363-0240Migraine ReliefIbuprofenWALGREENSANDACurrent
0363-0240Migraine ReliefIbuprofenWALGREENSANDACurrent
0363-0240Migraine ReliefIbuprofenWALGREENSANDACurrent
0363-0408IbuprofenIbuprofenWalgreensANDACurrent
0536-3603IbuprofenIBUPROFENRugby Laboratories, Inc.ANDACurrent
0536-3603IbuprofenIBUPROFENRugby Laboratories, Inc.ANDACurrent
11673-048IbuprofenIbuprofenTARGET CorporationANDACurrent
11673-197IbuprofenIBUPROFENTARGET CorporationANDACurrent
11673-197IbuprofenIBUPROFENTARGET CorporationANDACurrent
11673-197IbuprofenIBUPROFENTARGET CorporationANDACurrent
11822-0231IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-0231IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-0231IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-0589IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-0589IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-1879Dye-Free IbuprofenIbuprofenRITE AID CORPORATIONANDACurrent
11822-1879Dye-Free IbuprofenIbuprofenRITE AID CORPORATIONANDACurrent
11822-3307IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-3307IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-3307IbuprofenIbuprofenRite Aid CorporationANDACurrent
15127-316IbuprofenIbuprofenSelect Brand Dist.ANDACurrent
15127-316IbuprofenIbuprofenSelect Brand Dist.ANDACurrent
21130-197IbuprofenIbuprofenSafeway, Inc.ANDACurrent
21130-699IbuprofenIbuprofenSafeway, Inc.ANDACurrent
21130-699IbuprofenIbuprofenSafeway, Inc.ANDACurrent
24385-499Ibuprofen softgelsIbuprofenAmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385ANDACurrent
24385-499Ibuprofen softgelsIbuprofenAmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385ANDACurrent
27854-222ActrogelIbuprofenBelmora LLCANDACurrent
30142-048IbuprofenIbuprofenThe Kroger Co.ANDACurrent
30142-048IbuprofenIbuprofenThe Kroger Co.ANDACurrent
30142-048IbuprofenIbuprofenThe Kroger Co.ANDACurrent
30142-053IbuprofenIbuprofenKROGER COMPANYANDACurrent
30142-053IbuprofenIbuprofenKROGER COMPANYANDACurrent
30142-053IbuprofenIbuprofenKROGER COMPANYANDACurrent
30142-198IbuprofenIBUPROFENThe Kroger Co.ANDACurrent
30142-198IbuprofenIBUPROFENThe Kroger Co.ANDACurrent
33992-0199IbuprofenIbuprofenASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
33992-0199IbuprofenIbuprofenASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
36800-048IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-048IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-193IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-193IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-193IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-193IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-198IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-198IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-221IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-221IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
37012-199IbuprofenIbuprofenShopko Stores Operating Co., LLC.ANDACurrent
37205-736IbuprofenIbuprofenCardinal Health (Leader) 37205ANDACurrent
37205-736IbuprofenIbuprofenCardinal Health (Leader) 37205ANDACurrent
37205-736IbuprofenIbuprofenCardinal Health (Leader) 37205ANDACurrent
37808-198IbuprofenIbuprofenH E BANDACurrent
37808-198IbuprofenIbuprofenH E BANDACurrent
37808-198IbuprofenIbuprofenH E BANDACurrent
37808-609IbuprofenIbuprofenHEBANDACurrent
37808-609IbuprofenIbuprofenHEBANDACurrent
37808-609IbuprofenIbuprofenHEBANDACurrent
37808-699IbuprofenIbuprofenH E BANDACurrent
41163-198IbuprofenIbuprofenEQUALINE (SuperValu)ANDACurrent
41163-198IbuprofenIbuprofenEQUALINE (SuperValu)ANDACurrent
41250-048IbuprofenIbuprofenMEIJER, INC.ANDACurrent
41250-048IbuprofenIbuprofenMEIJER, INC.ANDACurrent
41250-198IbuprofenIbuprofenMEIJER, INC.ANDACurrent
41250-198IbuprofenIbuprofenMEIJER, INC.ANDACurrent
41250-198IbuprofenIbuprofenMEIJER, INC.ANDACurrent
41250-286IbuprofenIbuprofenMEIJER DISTRIBUTION INC.ANDACurrent
41250-286IbuprofenIbuprofenMEIJER DISTRIBUTION INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65844SUPPL2021-01-07
65843SUPPL2021-01-07
65842SUPPL2021-01-07
43144ORIG2011-09-19
23916ORIG2009-04-14