FDA.reportPublic FDA data

Application 091101

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXERCALCIFEROLDOXERCALCIFEROLINJECTABLE;INJECTION4MCG/2ML (2MCG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6154DoxercalciferolDoxercalciferolHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6154DoxercalciferolDoxercalciferolWest-Ward Pharmaceutical Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31517ORIG2013-09-04