FDA.report

Application 074937

Type
ANDA
Sponsor
PERRIGO

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S IBUPROFENIBUPROFENSUSPENSION;ORAL100MG/5MLNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0166good sense ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-0166good sense ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-0660Good Sense IbuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-0685Good Sense IbuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-0897good sense ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-7660basic care childrens ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-7897Basic Care childrens ibuprofenIbuprofenL Perrigo CompanyANDACurrent
0121-1836Childrens IbuprofenIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0363-0040IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-0166ibuprofenIbuprofenWalgreen CompanyANDACurrent
0363-0166ibuprofenIbuprofenWalgreen CompanyANDACurrent
0363-0660IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-0660IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-0660IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-0685IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-0806Childrens Ibuprofen 100IbuprofenWalgreen CompanyANDACurrent
0363-0806Childrens Ibuprofen 100IbuprofenWalgreen CompanyANDACurrent
0363-0806Childrens Ibuprofen 100IbuprofenWalgreen CompanyANDACurrent
0363-0897ibuprofenIbuprofenWalgreen CompanyANDACurrent
0363-0897ibuprofenIbuprofenWalgreen CompanyANDACurrent
0363-0897ibuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1501Childrens Ibuprofen 100IbuprofenWalgreen CompanyANDACurrent
0904-5309IbuprofenIbuprofenMajor PharmaceuticalsANDACurrent
0904-5309IbuprofenIbuprofenMajor PharmaceuticalsANDACurrent
0904-5577IbuprofenIbuprofenMajor PharmaceuticalsANDACurrent
10202-8977 Select Childrens IbuprofenIbuprofen7-ElevenANDACurrent
10202-8977 Select Childrens IbuprofenIbuprofen7-ElevenANDACurrent
11673-166Up and Up childrens ibuprofenIbuprofenTarget CorporationANDACurrent
11673-660up and up childrens ibuprofenIbuprofenTarget CorporationANDACurrent
11673-685up and up ibuprofenIbuprofenTarget CorporationANDACurrent
11822-0166Childrens IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-0660ibuprofenIbuprofenRite Aid CorporationANDACurrent
11822-0897ibuprofenIbuprofenRite Aid CorporationANDACurrent
17856-5309IbuprofenIbuprofenAtlantic Biologicals CorpsANDACurrent
17856-5309IbuprofenIbuprofenAtlantic Biologicals CorpsANDACurrent
17856-5309IbuprofenIbuprofenAtlantic Biologicals CorpsANDACurrent
21130-011signature care childrens ibuprofenIbuprofenSafewayANDACurrent
21130-035Signature Care Childrens IbuprofenIbuprofenSafewayANDACurrent
21130-606signature care ibuprofenIbuprofenSafewayANDACurrent
21130-911signature care childrens ibuprofenIbuprofenSafewayANDACurrent
24385-009Good Neighbor Pharmacy ibuprofenIbuprofenAmerisource BergenANDACurrent
24385-361Good Neighbor Pharmacy Childrens IbuprofenIbuprofenAmerisource BergenANDACurrent
24385-372Good Neighbor Pharmacy Childrens IbuprofenIbuprofenAmerisource BergenANDACurrent
24385-905good neighbor pharmacy ibuprofenIbuprofenAmerisource BergenANDACurrent
30142-166ibuprofenIbuprofenKroger CompanyANDACurrent
30142-166ibuprofenIbuprofenKroger CompanyANDACurrent
30142-166ibuprofenIbuprofenKroger CompanyANDACurrent
30142-660IbuprofenIbuprofenKroger CompanyANDACurrent
30142-660IbuprofenIbuprofenKroger CompanyANDACurrent
30142-660IbuprofenIbuprofenKroger CompanyANDACurrent
30142-685IbuprofenIbuprofenKroger CompanyANDACurrent
30142-685IbuprofenIbuprofenKroger CompanyANDACurrent
30142-685IbuprofenIbuprofenKroger CompanyANDACurrent
30142-897ibuprofenIbuprofenKroger CompanyANDACurrent
30142-897ibuprofenIbuprofenKroger CompanyANDACurrent
30142-897ibuprofenIbuprofenKroger CompanyANDACurrent
36800-166topcare childrens ibuprofenIbuprofenTopco Associates LLCANDACurrent
36800-166topcare childrens ibuprofenIbuprofenTopco Associates LLCANDACurrent
36800-166topcare childrens ibuprofenIbuprofenTopco Associates LLCANDACurrent
36800-166topcare childrens ibuprofenIbuprofenTopco Associates LLCANDACurrent
36800-660Topcare Childrens IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-660Topcare Childrens IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-660Topcare Childrens IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-660Topcare Childrens IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-660Topcare Childrens IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-685Topcare ibuprofenIbuprofenTopco Associates LLCANDACurrent
36800-685Topcare ibuprofenIbuprofenTopco Associates LLCANDACurrent
36800-685Topcare ibuprofenIbuprofenTopco Associates LLCANDACurrent
36800-685Topcare ibuprofenIbuprofenTopco Associates LLCANDACurrent
36800-897topcare ibuprofenIbuprofenTopco Associates LLCANDACurrent
36800-897topcare ibuprofenIbuprofenTopco Associates LLCANDACurrent
36800-897topcare ibuprofenIbuprofenTopco Associates LLCANDACurrent
37012-166childrens ibuprofenIbuprofenShopko Stores Operating Co., LLCANDACurrent
37012-685Childrens IbuprofenIbuprofenShopko Stores Operating Co., LLCANDACurrent
37012-897Childrens IbuprofenIbuprofenShopko Stores Operating Co., LLCANDACurrent
37808-023ibuprofenIbuprofenH E BANDACurrent
37808-023ibuprofenIbuprofenH E BANDACurrent
37808-200childrens ibuprofenIbuprofenH E BANDACurrent
37808-200childrens ibuprofenIbuprofenH E BANDACurrent
37808-363IbuprofenIbuprofenH E BANDACurrent

Documents

DocumentSubmission typeDate
39446ORIG1998-12-22
22386ORIG1998-12-22
8469ORIG1998-12-22