FDA.reportPublic FDA data

Application 089338

Type
ANDA
Sponsor
SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUINIDINE GLUCONATEQUINIDINE GLUCONATETABLET, EXTENDED RELEASE;ORAL324MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51407-288Quinidine GluconateQuinidine GluconateGolden State Medical SupplyANDACurrent
53489-141Quinidine GluconateQuinidine GluconateSun Pharmaceutical Industries, Inc.ANDACurrent
54738-901Quinidine GluconateQuinidine GluconateRichmond Pharmaceuticals, Inc.ANDACurrent
68151-2701Quinidine GluconateQuinidine GluconateCarilion Materials ManagementANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39599SUPPL2010-03-17