Application 212589

Type
ANDA
Sponsor
EYWA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUINIDINE GLUCONATEQUINIDINE GLUCONATETABLET, EXTENDED RELEASE;ORAL324MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71930-016Quinidine gluconateQuinidine gluonateEywa Pharma IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68922ORIG2021-10-08