FDA.reportPublic FDA data

Application 078193

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDETABLET;ORAL60MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7290Raloxifene HydrochlorideRaloxifene HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7290Raloxifene HydrochlorideRaloxifene HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7290Raloxifene HydrochlorideRaloxifene HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7290Raloxifene HydrochlorideRaloxifene HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7290Raloxifene HydrochlorideRaloxifene HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7290Raloxifene HydrochlorideRaloxifene HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7290Raloxifene HydrochlorideRaloxifene HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-726Raloxifene HydrochlorideRaloxifene HydrochlorideAvKARE, Inc.ANDACurrent
42291-726Raloxifene HydrochlorideRaloxifene HydrochlorideAvKAREANDACurrent
68071-2412Raloxifene HydrochlorideRaloxifene HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2994Raloxifene HydrochlorideRaloxifene HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-1715Raloxifene HydrochlorideRaloxifene HydrochlorideBryant Ranch PrepackANDACurrent
71335-1715Raloxifene HydrochlorideRaloxifene HydrochlorideBryant Ranch PrepackANDACurrent
71610-504Raloxifene HydrochlorideRaloxifene HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52769ORIG2018-02-28
9129ORIG2014-03-06