FDA.reportPublic FDA data

Application 075217

Type
ANDA
Sponsor
L PERRIGO CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENSUSPENSION/DROPS;ORAL40MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0040Good Sense Infants IbuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-0057Good Sense ibuprofenibuprofenL. Perrigo CompanyANDACurrent
0363-0057IbuprofenibuprofenWalgreen CompanyANDACurrent
0363-0057IbuprofenibuprofenWalgreen CompanyANDACurrent
0363-0255ibuprofenIbuprofenWalgreen CompanyANDACurrent
0363-0255ibuprofenIbuprofenWalgreen CompanyANDACurrent
0363-2323infants dye free ibuprofenIbuprofenWalgreen CompanyANDACurrent
0363-2323infants dye free ibuprofenIbuprofenWalgreen CompanyANDACurrent
0904-5463ibuprofenibuprofenMajor PharmaceuticalsANDACurrent
11673-255up and up dye free infants concentrated ibuprofenIbuprofenTarget CorporationANDACurrent
11822-0255ibuprofenIbuprofenRite Aid CorporationANDACurrent
11822-0255ibuprofenIbuprofenRite Aid CorporationANDACurrent
11822-0255ibuprofenIbuprofenRite Aid CorporationANDACurrent
11822-0255ibuprofenIbuprofenRite Aid CorporationANDACurrent
11822-0255ibuprofenIbuprofenRite Aid CorporationANDACurrent
21130-363signature care infants ibuprofenIbuprofenSafewayANDACurrent
21130-363signature care infants ibuprofenIbuprofenSafewayANDACurrent
24385-550good neighbor pharmacy ibuprofenIbuprofenAmerisource BergenANDACurrent
30142-057ibuprofenibuprofenKroger CompanyANDACurrent
30142-057ibuprofenibuprofenKroger CompanyANDACurrent
30142-255ibuprofenIbuprofenKroger CompanyANDACurrent
30142-255ibuprofenIbuprofenKroger CompanyANDACurrent
30142-255ibuprofenIbuprofenKroger CompanyANDACurrent
36800-057Topcare Infants IbuprofenibuprofenTopco Associates LLCANDACurrent
36800-057Topcare Infants IbuprofenibuprofenTopco Associates LLCANDACurrent
36800-057Topcare Infants IbuprofenibuprofenTopco Associates LLCANDACurrent
36800-255Topcare IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-255Topcare IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-255Topcare IbuprofenIbuprofenTopco Associates LLCANDACurrent
37012-255Infants IbuprofenIbuprofenShopko Stores Operating Co., LLCANDACurrent
37205-436Leader IbuprofenIbuprofenCardinal HealthANDACurrent
37808-057ibuprofenibuprofenH E BANDACurrent
37808-255infants ibuprofenIbuprofenH E BANDACurrent
37808-255infants ibuprofenIbuprofenH E BANDACurrent
41163-057Equaline IbuprofenibuprofenSupervalu IncANDACurrent
41163-057Equaline IbuprofenibuprofenSupervalu IncANDACurrent
41163-255equaline ibuprofenIbuprofenSupervalu IncANDACurrent
41163-255equaline ibuprofenIbuprofenSupervalu IncANDACurrent
41190-255ShopRite Infants IbuprofenIbuprofenWakefern Food CorporationANDACurrent
41190-255ShopRite Infants IbuprofenIbuprofenWakefern Food CorporationANDACurrent
41250-057ibuprofenibuprofenMeijer Distribution IncANDACurrent
41250-057ibuprofenibuprofenMeijer Distribution IncANDACurrent
41250-255ibuprofenIbuprofenMeijer Distribution IncANDACurrent
41520-057care one ibuprofenibuprofenAmerican Sales CompanyANDACurrent
41520-255care one ibuprofenIbuprofenAmerican Sales CompanyANDACurrent
42507-057ibuprofenibuprofenHyVee IncANDACurrent
42507-255ibuprofenIbuprofenHyVee IncANDACurrent
45802-057IbuprofenibuprofenPerrigo New York IncANDACurrent
45802-057IbuprofenibuprofenPadagis Israel Pharmaceuticals LtdANDACurrent
49035-601parents choice infants ibuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-601parents choice infants ibuprofenIbuprofenWal-Mart Stores IncANDACurrent
49348-374sunmark ibuprofenibuprofenStrategic Sourcing Services LLCANDACurrent
49348-374sunmark ibuprofenibuprofenStrategic Sourcing Services LLCANDACurrent
49348-374sunmark ibuprofenibuprofenMcKessonANDACurrent
49348-642sunmark ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
49348-642sunmark ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
49348-642sunmark ibuprofenIbuprofenMcKessonANDACurrent
49738-255smart sense ibuprofenIbuprofenKmart CorporationANDACurrent
55316-057healthy accents ibuprofenibuprofenDZA Brands LLCANDACurrent
55316-255healthy accents ibuprofenIbuprofenDZA Brands LLCANDACurrent
55319-054kidgets infantsibuprofenFamily Dollar Services IncANDACurrent
55910-057Health Sense Infants IbuprofenibuprofenDolgencorp IncANDACurrent
55910-255dg health ibuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-255dg health ibuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-503Dg Health IbuprofenibuprofenDolgencorp, LLCANDACurrent
55910-503Dg Health IbuprofenibuprofenDolgencorp, LLCANDACurrent
56062-057profen ibibuprofenPublix Super Markets IncANDACurrent
56062-255ibuprofenIbuprofenPublix Super Markets IncANDACurrent
56062-404profen ibIbuprofenPublix Super Markets IncANDACurrent
59779-313ibuprofenIbuprofenCVS PharmacyANDACurrent
59779-313ibuprofenIbuprofenCVS PharmacyANDACurrent
59779-995infants ibuprofenibuprofenCVS PharmacyANDACurrent
59779-995infants ibuprofenibuprofenCVS PharmacyANDACurrent
62011-0004health mart ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0004health mart ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0004health mart ibuprofenIbuprofenMcKessonANDACurrent
62011-0012health mart ibuprofenibuprofenStrategic Sourcing Services LLCANDACurrent
62011-0012health mart ibuprofenibuprofenMcKessonANDACurrent
62011-0012health mart ibuprofenibuprofenStrategic Sourcing Services LLCANDACurrent
64024-255Welby Infants IbuprofenIbuprofenAldi IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42960ORIG1998-12-16
39466ORIG1998-12-16
8567ORIG1998-12-16