FDA.reportPublic FDA data

Application 060593

Type
ANDA
Sponsor
PURDUE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEROMYCINCYCLOSERINECAPSULE;ORAL250MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13845-1200SEROMYCINCYCLOSERINEParsolex Gmp Center, Inc.ANDACurrent
13845-1200SEROMYCINCYCLOSERINEPurdue GMP Center LLC dba The Chao CenterANDACurrent
13845-1201CYCLOSERINECYCLOSERINEParsolex Gmp Center, Inc.ANDACurrent
13845-1201CYCLOSERINECYCLOSERINEPurdue GMP Center LLC dba The Chao CenterANDACurrent
13845-1202CycloserineCycloserinePurdue GMP Center LLCANDACurrent
13845-1202CycloserineCycloserineParsolex Gmp Center, Inc.ANDACurrent
13845-1203SeromycinCycloSERINEParsolex Gmp Center, Inc.ANDACurrent