FDA.reportPublic FDA data

Application 210579

Type
ANDA
Sponsor
MISEMER

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
0276-0500Not applicableChlordiazepoxide Hydrochloride and Clidinium Bromide CapsulesMisemer Pharmaceuticals, IncANDACurrent
0276-0500Not applicableChlordiazepoxide Hydrochloride and Clidinium Bromide CapsulesMisemer Pharmaceuticals, IncANDACurrent
0276-0500Not applicableChlordiazepoxide Hydrochloride and Clidinium Bromide CapsulesMisemer Pharmaceuticals, IncANDACurrent
0276-0500Not applicableChlordiazepoxide Hydrochloride and Clidinium Bromide CapsulesMisemer Pharmaceuticals, IncANDACurrent
23155-808chlordiazepoxide hydrochloride and clidinium bromidechlordiazepoxide hydrochloride and clidinium bromideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-808chlordiazepoxide hydrochloride and clidinium bromidechlordiazepoxide hydrochloride and clidinium bromideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-808chlordiazepoxide hydrochloride and clidinium bromidechlordiazepoxide hydrochloride and clidinium bromideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-808chlordiazepoxide hydrochloride and clidinium bromidechlordiazepoxide hydrochloride and clidinium bromideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
70700-185Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideXiromed, LLCANDACurrent