FDA.reportPublic FDA data

Application 091133

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8403BenzonatateBenzonatateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
64380-712BenzonatateBenzonatateStrides Pharma Science LimitedANDACurrent
64380-712BenzonatateBenzonatateStrides Pharma Science LimitedANDACurrent
64380-712BenzonatateBenzonatateStrides Shasun LimitedANDACurrent
64380-712BenzonatateBenzonatateStrides Pharma Science LimitedANDACurrent
64380-712BenzonatateBenzonatateStrides Pharma Science LimitedANDACurrent
64380-713BenzonatateBenzonatateStrides Pharma Science LimitedANDACurrent
64380-713BenzonatateBenzonatateStrides Pharma Science LimitedANDACurrent
64380-713BenzonatateBenzonatateStrides Shasun LimitedANDACurrent
64380-713BenzonatateBenzonatateStrides Pharma Science LimitedANDACurrent
64380-713BenzonatateBenzonatateStrides Pharma Science LimitedANDACurrent
68071-1877BenzonatateBenzonatateNuCare Pharmaceuticals, Inc.ANDACurrent
68788-7014BenzonatateBenzonatatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7014BenzonatateBenzonatatePreferred Pharmaceuticals Inc.ANDACurrent
70934-925BenzonatateBenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-925BenzonatateBenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent