FDA.reportPublic FDA data

Application 200181

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENELZINE SULFATEPHENELZINE SULFATETABLET;ORALEQ 15MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-360Phenelzine SulfatePhenelzine SulfateNovel Laboratories, Inc.ANDACurrent
43386-360Phenelzine SulfatePhenelzine SulfateLupin Pharmaceuticals,Inc.ANDACurrent