FDA.reportPublic FDA data

Application 210257

Type
ANDA
Sponsor
FRESENIUS KABI USA

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
51662-1559DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
63323-842Dicyclomine HydrochlorideDicyclomine HydrochlorideFresenius Kabi USA, LLCANDACurrent
63323-842Dicyclomine HydrochlorideDicyclomine HydrochlorideFresenius Kabi USA, LLCANDACurrent