FDA.reportPublic FDA data

Application 211314

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINCAPSULE;ORAL100MGNoNo
002GABAPENTINGABAPENTINCAPSULE;ORAL300MGNoNo
003GABAPENTINGABAPENTINCAPSULE;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64380-867GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
64380-867GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
64380-867GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
64380-867GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
64380-867GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
64380-868GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
64380-868GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
64380-868GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
64380-868GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
64380-868GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
64380-869GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
64380-869GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
64380-869GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
64380-869GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
64380-869GABAPENTINgabapentinStrides Pharma Science LimitedANDACurrent
70934-621GABAPENTINgabapentinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-635GABAPENTINgabapentinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent