FDA.reportPublic FDA data

Application 090842

Type
ANDA
Sponsor
INVAGEN PHARMS

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
0440-5295Raloxifene HydrochlorideRaloxifene HydrochlorideLiberty Pharmaceuticals, Inc.ANDACurrent
31722-256Raloxifene HydrochlorideRaloxifene HydrochlorideCamber Pharmaceuticals IncANDACurrent
50090-5458Raloxifene HydrochlorideRaloxifeneA-S Medication SolutionsANDACurrent
60687-266Raloxifene HydrochlorideRaloxifeneAmerican Health PackagingANDACurrent
60687-266Raloxifene HydrochlorideRaloxifeneAmerican Health PackagingANDACurrent
60687-266Raloxifene HydrochlorideRaloxifeneAmerican Health PackagingANDACurrent
60687-266Raloxifene HydrochlorideRaloxifeneAmerican Health PackagingANDACurrent
60687-266Raloxifene HydrochlorideRaloxifeneAmerican Health PackagingANDACurrent
63629-7708Raloxifene HydrochlorideRaloxifeneBryant Ranch PrepackANDACurrent
63629-7708Raloxifene HydrochlorideRaloxifeneBryant Ranch PrepackANDACurrent
69097-825Raloxifene HydrochlorideRaloxifeneCipla USA Inc.ANDACurrent
69097-825Raloxifene HydrochlorideRaloxifeneCipla USA Inc.ANDACurrent
69097-825Raloxifene HydrochlorideRaloxifeneCipla USA Inc.ANDACurrent
70518-3046Raloxifene HydrochlorideRaloxifeneREMEDYREPACK INC.ANDACurrent
71335-1663Raloxifene HydrochlorideRaloxifeneBryant Ranch PrepackANDACurrent
71335-1663Raloxifene HydrochlorideRaloxifeneBryant Ranch PrepackANDACurrent
71610-524Raloxifene HydrochlorideRaloxifeneAphena Pharma Solutions - Tennessee, LLCANDACurrent
76282-256Raloxifene HydrochlorideRaloxifene HydrochlorideExelan Pharmaceuticals, Inc.ANDACurrent
76282-256Raloxifene HydrochlorideRaloxifene HydrochlorideExelan Pharmaceuticals, Inc.ANDACurrent
76282-256Raloxifene HydrochlorideRaloxifene HydrochlorideExelan Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54299ORIG2018-05-22