Application 213070

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDECAPSULE;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59556-959Loperamide HydrochlorideLoperamide HydrochlorideStrides Pharma IncANDACurrent
59556-959Loperamide HydrochlorideLoperamide HydrochlorideStrides Pharma IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68523ORIG2021-09-02