FDA.reportPublic FDA data

Application 088483

Type
ANDA
Sponsor
ODYSSEY PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANTABUSEDISULFIRAMTABLET;ORAL500MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5036DisulfiramDisulfiramTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5036DisulfiramDisulfiramTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5036DisulfiramDisulfiramTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5036DisulfiramDisulfiramTeva Pharmaceuticals USA, Inc.ANDACurrent
51285-524AntabuseDisulfiramTeva Women's Health, Inc.ANDACurrent
51285-524AntabuseDisulfiramTeva Women's Health, Inc.ANDACurrent
51285-524AntabuseDisulfiramTeva Women's Health, Inc.ANDACurrent
51285-524AntabuseDisulfiramTeva Women's Health, Inc.ANDACurrent
51285-524AntabuseDisulfiramTeva Women's Health, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22692ORIG1999-04-13