FDA.reportPublic FDA data

Application 088441

Type
ANDA
Sponsor
ODYSSEY PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001URECHOLINEBETHANECHOL CHLORIDETABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50111-325Bethanechol ChlorideBethanechol ChlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-325Bethanechol ChlorideBethanechol ChlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-325Bethanechol ChlorideBethanechol ChlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
51285-691UrecholineBethanechol ChlorideTeva Women's Health, Inc.ANDACurrent
51285-691UrecholineBethanechol ChlorideTeva Women's Health, Inc.ANDACurrent
51285-691UrecholineBethanechol ChlorideTeva Women's Health, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22690ORIG2007-07-09