FDA.reportPublic FDA data

Application 076037

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDETABLET;ORAL50MGNoNo
002NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDETABLET;ORAL100MGNoNo
003NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDETABLET;ORAL150MGNoNo
004NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDETABLET;ORAL200MGNoNo
005NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDETABLET;ORAL250MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-1024Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1024Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1024Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1024Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1024Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1025Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1025Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1025Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1025Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1025Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1026Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1026Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1026Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1026Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1026Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7113Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7113Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7113Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7113Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7113Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7178Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7178Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7178Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7178Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7178Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
21695-174Nefazodone HydrochlorideNefazodone HydrochlorideRebel Distributors CorpANDACurrent
21695-175Nefazodone HydrochlorideNefazodone HydrochlorideRebel Distributors CorpANDACurrent
21695-176Nefazodone HydrochlorideNefazodone HydrochlorideRebel Distributors CorpANDACurrent
21695-177Nefazodone HydrochlorideNefazodone HydrochlorideRebel Distributors CorpANDACurrent
63629-7046Nefazodone HydrochlorideNefazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-7046Nefazodone HydrochlorideNefazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-7046Nefazodone HydrochlorideNefazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-7214Nefazodone HydrochlorideNefazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-7214Nefazodone HydrochlorideNefazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-7310Nefazodone HydrochlorideNefazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-7310Nefazodone HydrochlorideNefazodone HydrochlorideBryant Ranch PrepackANDACurrent
68788-7217Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7217Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7217Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7242Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7242Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7242Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7246Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7246Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7246Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39501SUPPL2014-09-05
44283ORIG2007-05-09