FDA.reportPublic FDA data

Application 091433

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXERCALCIFEROLDOXERCALCIFEROLCAPSULE;ORAL0.5MCGNoNo
002DOXERCALCIFEROLDOXERCALCIFEROLCAPSULE;ORAL1MCGNoNo
003DOXERCALCIFEROLDOXERCALCIFEROLCAPSULE;ORAL2.5MCGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0338DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0338DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0338DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0338DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0338DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0339DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0339DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0339DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0339DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0339DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0388DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0388DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0388DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0388DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0388DoxercalciferolDoxercalciferolWest-Ward Pharmaceuticals Corp.ANDACurrent
68084-872DoxercalciferolDoxercalciferolAmerican Health PackagingANDACurrent
68084-872DoxercalciferolDoxercalciferolAmerican Health PackagingANDACurrent
68084-872DoxercalciferolDoxercalciferolAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9339ORIG2011-11-07