FDA.reportPublic FDA data

Application 211421

Type
ANDA
Sponsor
SUNRISE PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDECHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDECAPSULE;ORAL5MG;2.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11534-197Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideSunrise Pharmaceutical, Inc.ANDACurrent
11534-197Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideSunrise Pharmaceutical, Inc.ANDACurrent
11534-197Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideSunrise Pharmaceutical, Inc.ANDACurrent
63629-2373Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideBryant Ranch PrepackANDACurrent
63629-2373Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideBryant Ranch PrepackANDACurrent
63629-2373Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideBryant Ranch PrepackANDACurrent
63629-2373Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64422ORIG2020-08-26