FDA.reportPublic FDA data

Application 040465

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)DICYCLOMINE HYDROCHLORIDEINJECTABLE;INJECTION10MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6173Dicyclomine HydrochlorideDicyclomine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6173Dicyclomine HydrochlorideDicyclomine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6173Dicyclomine HydrochlorideDicyclomine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent