FDA.reportPublic FDA data

Application 208353

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEINJECTABLE;INJECTION10MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-1980Dicyclomine hydrochlorideDicyclomine hydrochlorideAmerican Regent, Inc.ANDACurrent
0517-1980Dicyclomine hydrochlorideDicyclomine hydrochlorideAmerican Regent, Inc.ANDACurrent