FDA.reportPublic FDA data

Application 040169

Type
ANDA
Sponsor
GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDESYRUP;ORAL10MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-1161dicyclomine hydrochloridedicyclomine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-1161dicyclomine hydrochloridedicyclomine hydrochloridePar PharmaceuticalANDACurrent
17856-1161dicyclomine hydrochloridedicyclomine hydrochlorideAtlantic Biologicals CorpsANDACurrent
46672-657dicyclomine hydrochloridedicyclomine hydrochlorideMikart, Inc.ANDACurrent
53703-800Dicyclomine HydrochlorideDicyclomine HydrochlorideEntera Health, Inc.ANDACurrent
63629-2179dicyclomine hydrochloridedicyclomine hydrochlorideBryant Ranch PrepackANDACurrent
63629-2179dicyclomine hydrochloridedicyclomine hydrochlorideBryant Ranch PrepackANDACurrent
68151-1161dicyclomine hydrochloridedicyclomine hydrochlorideCarilion Materials ManagementANDACurrent