FDA.reportPublic FDA data

Application 211518

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZONATATEBENZONATATECAPSULE;ORAL100MGNoNo
002BENZONATATEBENZONATATECAPSULE;ORAL150MGNoNo
003BENZONATATEBENZONATATECAPSULE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-956BenzonatateBenzonatateCamber Pharmaceuticals, Inc.ANDACurrent
31722-956BenzonatateBenzonatateCamber Pharmaceuticals, Inc.ANDACurrent
31722-957BenzonatateBenzonatateCamber Pharmaceuticals, Inc.ANDACurrent
31722-957BenzonatateBenzonatateCamber Pharmaceuticals, Inc.ANDACurrent
31722-958BenzonatateBenzonatateCamber Pharmaceuticals, Inc.ANDACurrent
31722-958BenzonatateBenzonatateCamber Pharmaceuticals, Inc.ANDACurrent
50090-6080BenzonatateBenzonatateA-S Medication SolutionsANDACurrent
50090-6205BenzonatateBenzonatateA-S Medication SolutionsANDACurrent
50090-6228BenzonatateBenzonatateA-S Medication SolutionsANDACurrent
63629-1229BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-1229BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-1229BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
68071-2562BenzonatateBenzonatateNuCare Pharmaceuticals,Inc.ANDACurrent
71205-673BenzonatateBenzonatateProficient Rx LPANDACurrent
71205-699BenzonatateBenzonatateProficient Rx LPANDACurrent
71205-853BenzonatateBenzonatateProficient Rx LPANDACurrent
71205-887BenzonatateBenzonatateProficient Rx LPANDACurrent
71205-887BenzonatateBenzonatateProficient Rx LPANDACurrent
72865-117BenzonatateBenzonatateXLCare Pharmaceuticals, IncANDACurrent
72865-117BenzonatateBenzonatateXLCare Pharmaceuticals, Inc.ANDACurrent
72865-118BenzonatateBenzonatateXLCare Pharmaceuticals, IncANDACurrent
72865-118BenzonatateBenzonatateXLCare Pharmaceuticals, Inc.ANDACurrent
72865-119BenzonatateBenzonatateXLCare Pharmaceuticals, IncANDACurrent
72865-119BenzonatateBenzonatateXLCare Pharmaceuticals, Inc.ANDACurrent