FDA.reportPublic FDA data

Application 079058

Type
ANDA
Sponsor
TRIS PHARMA INC

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
0363-1252Infants IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1252Infants IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-5100Infants IbuprofenIbuprofenWalgreensANDACurrent
0363-5100Infants IbuprofenIbuprofenWalgreensANDACurrent
0363-5100Infants IbuprofenIbuprofenWalgreensANDACurrent
11822-1250Infants IbuprofenIbuprofenRite AidANDACurrent
45963-125Infants IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
49035-125Infants IbuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-125Infants IbuprofenIbuprofenWal-Mart Stores IncANDACurrent
55319-250Infants IbuprofenIbuprofenFamily Dollar Services Inc.ANDACurrent
59779-925Infants IbuprofenIbuprofenCVS PharmacyANDACurrent
63029-900PediaCare InfantsIbuprofenMedtech Products Inc.ANDACurrent
63868-076Infants IbuprofenIbuprofenChain Drug Marketing Association Inc.ANDACurrent
63941-125Infants IbuprofenIbuprofenBest Choice (Valu Merchandisers Company)ANDACurrent
63941-125Infants IbuprofenIbuprofenValu Merchandisers CompanyANDACurrent
68016-125Infants IbuprofenIbuprofenChain Drug Consortium, LLCANDACurrent
71205-110Infants IbuprofenIbuprofenProficient Rx LPANDACurrent
71205-110Infants IbuprofenIbuprofenProficient Rx LPANDACurrent