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

NDC Listings For This Application#

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