FDA.reportPublic FDA data

Application 076359

Type
ANDA
Sponsor
PERRIGO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET, CHEWABLE;ORAL50MGNoNo
002IBUPROFENIBUPROFENTABLET, CHEWABLE;ORAL100MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0461Good Sense ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-0461Good Sense ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-0788Basic Care ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-1461basic care childrens ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-1461basic care childrens ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-2461Good Sense Childrens IbuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-7619basic care childrens ibuprofenibuprofenL. Perrigo CompanyANDACurrent
0363-0507IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-0521IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-0523IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1461childrens ibuprofen 100ibuprofenWalgreen CompanyANDACurrent
0363-1461childrens ibuprofen 100ibuprofenWalgreen CompanyANDACurrent
0363-1521childrens ibuprofen 100ibuprofenWalgreen CompanyANDACurrent
0363-1521childrens ibuprofen 100ibuprofenWalgreen CompanyANDACurrent
11673-461Up and Up IbuprofenIbuprofenTarget CorporationANDACurrent
11673-521up and up junior strength ibuprofenIbuprofenTarget CorporationANDACurrent
11673-593Up and Up Childrens IbuprofenibuprofenTarget CorporationANDACurrent
11673-593Up and Up Childrens IbuprofenibuprofenTarget CorporationANDACurrent
11673-741Up and Up Childrens IbuprofenibuprofenTarget CorporationANDACurrent
11673-741Up and Up Childrens IbuprofenibuprofenTarget CorporationANDACurrent
11822-0010ibuprofenIbuprofenRite Aid CorporationANDACurrent
11822-0521ibuprofenIbuprofenRite Aid CorporationANDACurrent
11822-1521childrens ibuprofenIbuprofenRite Aid CorporationANDACurrent
11822-4461Childrens IbuprofenIbuprofenRite Aid CorporationANDACurrent
21130-026Signature Care IbuprofenIbuprofenSafewayANDACurrent
21130-701signature care childrens ibuprofenibuprofenSafewayANDACurrent
21130-701signature care childrens ibuprofenibuprofenSafewayANDACurrent
24385-546good neighbor pharmacy ibuprofenIbuprofenAmerisource BergenANDACurrent
30142-402childrens ibuprofenibuprofenKroger CompanyANDACurrent
30142-402childrens ibuprofenibuprofenKroger CompanyANDACurrent
30142-461ibuprofenIbuprofenKroger CompanyANDACurrent
30142-513childrens ibuprofenibuprofenKroger CompanyANDACurrent
30142-513childrens ibuprofenibuprofenKroger CompanyANDACurrent
30142-521junior strength ibuprofenIbuprofenKroger CompanyANDACurrent
36800-461Topcare IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-811topcare childrens ibuprofenibuprofenTopco Associates LLCANDACurrent
36800-811topcare childrens ibuprofenibuprofenTopco Associates LLCANDACurrent
37012-461Junior Strength IbuprofenIbuprofenShopko Stores Operating Co., LLCANDACurrent
37012-521IbuprofenIbuprofenShopko Stores Operating Co., LLCANDACurrent
41163-521equaline ibuprofenIbuprofenSupervalu IncANDACurrent
41163-710equaline childrens ibuprofenibuprofenSupervalu IncANDACurrent
41190-461ShopRite Ibuprofen IBIbuprofenWakefern Food CorporationANDACurrent
41250-331childrens ibuprofenibuprofenMeijer Distribution IncANDACurrent
41250-461ibuprofenIbuprofenMeijer Distribution IncANDACurrent
41250-461ibuprofenIbuprofenMeijer Distribution IncANDACurrent
41250-521ibuprofenIbuprofenMeijer Distribution IncANDACurrent
41250-726childrens ibuprofenibuprofenMeijer Distribution IncANDACurrent
41250-726childrens ibuprofenibuprofenMeijer Distribution IncANDACurrent
41520-521Care One IbuprofenIbuprofenAmerican Sales CompanyANDACurrent
41520-600Careone ibuprofen junior strengthIbuprofenAmerican Sales CompanyANDACurrent
41520-633careone childrens ibuprofenibuprofenAmerican Sales CompanyANDACurrent
41520-740careone childrens ibuprofenibuprofenAmerican Sales CompanyANDACurrent
41520-740careone childrens ibuprofenibuprofenAmerican Sales CompanyANDACurrent
41520-933careone ibuprofenIbuprofenAmerican Sales CompanyANDACurrent
41520-933careone ibuprofenIbuprofenAmerican Sales CompanyANDACurrent
46122-010Good Neighbor Pharmacy IbuprofenIbuprofenAmerisource BergenANDACurrent
46122-010Good Neighbor Pharmacy IbuprofenIbuprofenAmerisource BergenANDACurrent
46122-617Good Neighbor Pharmacy Childrens IbuprofenIbuprofenAmerisource BergenANDACurrent
46122-617Good Neighbor Pharmacy Childrens IbuprofenIbuprofenAmerisource BergenANDACurrent
46122-632good neighbor pharmacy childrens ibuprofenIbuprofenAmerisource BergenANDACurrent
49035-521equate ibuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-521equate ibuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-521equate ibuprofenIbuprofenWal-Mart Stores IncANDACurrent
49348-639Sunmark Ibuprofen IBIbuprofenMcKessonANDACurrent
49348-639Sunmark Ibuprofen IBIbuprofenStrategic Sourcing Services LLCANDACurrent
49738-461smart sense ibuprofenIbuprofenKmart CorporationANDACurrent
50580-932Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-932Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-932Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-932Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-933Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-933Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-933Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-933Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
55316-461Healthy Accents IbuprofenIbuprofenDZA Brands LLCANDACurrent
55316-521healthy accents ibuprofenIbuprofenDZA Brands LLCANDACurrent
55910-521rexall ibuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-521rexall ibuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-521rexall ibuprofenIbuprofenDolgencorp, LLCANDACurrent
56062-461ibuprofenIbuprofenPublix Super Markets IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8900ORIG2004-01-22