Application 207076

Type
ANDA
Sponsor
SLATE

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
70436-014Dicyclomine HydrochlorideDicyclomine HydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-014Dicyclomine HydrochlorideDicyclomine HydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-147Dicyclomine HydrochlorideDicyclomine HydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent