FDA.reportPublic FDA data

Application 074978

Type
ANDA
Sponsor
ACTAVIS MID ATLANTIC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENSUSPENSION;ORAL100MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0472-1270IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-2002IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-2002IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-2002IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-2002IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-2002IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-2002IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
55154-4060IbuprofenIbuprofenCardinal HealthANDACurrent
55154-4065IbuprofenIbuprofenCardinal HealthANDACurrent
55154-4065IbuprofenIbuprofenCardinal Health 107, LLCANDACurrent
66689-009IbuprofenIbuprofenVistaPharm, Inc.ANDACurrent
66689-009IbuprofenIbuprofenVistaPharm, Inc.ANDACurrent
66689-339IbuprofenIbuprofenVistaPharm, Inc.ANDACurrent
66689-339IbuprofenIbuprofenVistaPharm, Inc.ANDACurrent
66689-339IbuprofenIbuprofenVistaPharm, Inc.ANDACurrent
66689-339IbuprofenIbuprofenVistaPharm, Inc.ANDACurrent
71205-367IbuprofenIbuprofenProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39450ORIG2014-12-19
8480SUPPL2014-11-13
22397ORIG1998-03-25