FDA.report

Application 074916

Type
ANDA
Sponsor
P AND L

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENSUSPENSION;ORAL100MG/5MLNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0914Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-0914Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-0914Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-0914Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-0914Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-0917Childrens IbuprofenIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-0917Childrens IbuprofenIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-0917Childrens IbuprofenIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-1820Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-1828Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-1828Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-1828Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-1828Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0363-1255Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1261Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1262Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1263Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1761Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1761Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-1761Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-1762Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1762Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-1762Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-1763Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1763Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-1763Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-1764Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1764Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-1764Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-4560IbuprofenIbuprofenWalgreensANDACurrent
0363-7610Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-7610Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-7610Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-9370IbuprofenIbuprofenWalgreensANDACurrent
0363-9370IbuprofenIbuprofenWalgreensANDACurrent
0472-1255Childrens IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1261Childrens IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1263Childrens IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1760IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1760IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1760IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1761IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1761IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1761IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1763IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1763IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1763IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1763IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1764IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1764IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1764IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
11822-1261Childrens IbuprofenIbuprofenRite AidANDACurrent
11822-1761IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-1761IbuprofenIbuprofenRite AidANDACurrent
11822-3061IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-3061IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-3310IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-3310IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-6159IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-9380IbuprofenIbuprofenRite Aid CorporationANDACurrent
49035-126Childrens IbuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-716IbuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-716IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-716IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDACurrent
50090-2528Childrens IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-3517IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
55319-263Childrens IbuprofenIbuprofenFamily Dollar Services Inc.ANDACurrent
55319-763IbuprofenIbuprofenFamily Dollar Services InANDACurrent
55319-763IbuprofenIbuprofenFamily Dollar Services Inc.ANDACurrent
61269-761Childrens IbuprofenIBUPROFENH2-Pharma, LLCANDACurrent
61269-761Childrens IbuprofenIBUPROFENH2-Pharma, LLCANDACurrent
61269-763Childrens IbuprofenibuprofenH2-Pharma, LLCANDACurrent
61269-763Childrens IbuprofenibuprofenH2-Pharma, LLCANDACurrent
63187-166Childrens IbuprofenIbuprofenProficient Rx LPANDACurrent
63868-709IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-709IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-709IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-724IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-724IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-724IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent

Documents

DocumentSubmission typeDate
8463ORIG1998-01-09