FDA.reportPublic FDA data

Application 018044

Type
NDA
Sponsor
VALIDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROCALTROLCALCITRIOLCAPSULE;ORAL0.25MCGYesNo
002ROCALTROLCALCITRIOLCAPSULE;ORAL0.5MCGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
30698-143RocaltrolcalcitriolValidus Pharmaceuticals LLCNDACurrent
30698-143RocaltrolcalcitriolValidus Pharmaceuticals LLCNDACurrent
30698-144RocaltrolcalcitriolValidus Pharmaceuticals LLCNDACurrent
30698-144RocaltrolcalcitriolValidus Pharmaceuticals LLCNDACurrent
43353-138CALCITRIOLCALCITRIOLAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-633RocaltrolcalcitriolAphena Pharma Solutions - Tennessee, Inc.NDACurrent
63304-239CALCITRIOLCALCITRIOLSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
63304-240CALCITRIOLCALCITRIOLSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
66336-851CALCITRIOLCALCITRIOLDispensing Solutions, Inc.NDA AUTHORIZED GENERICCurrent
68151-0088CALCITRIOLCALCITRIOLCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
810SUPPL2010-03-03
809SUPPL2004-07-08
13996SUPPL2004-06-16
13997SUPPL2002-02-01
40775SUPPL1998-05-06
40774SUPPL1998-05-06
20105SUPPL1998-05-06