FDA.reportPublic FDA data

Application 203243

Type
ANDA
Sponsor
NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLARITHROMYCINCLARITHROMYCINTABLET, EXTENDED RELEASE;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-238CLARITHROMYCINCLARITHROMYCIN EXTENDED-RELEASEPar Pharmaceutical, Inc.ANDACurrent
72763-100Clarithromycin Extended-ReleaseCLARITHROMYCINEstreno Pharmaceuticals, LLCANDACurrent