FDA.reportPublic FDA data

Application 125511

Type
BLA
Sponsor
NPS PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NATPARAPARATHYROID HORMONEINJECTABLE;INJECTION25MCGYesNo
002NATPARAPARATHYROID HORMONEINJECTABLE;INJECTION50MCGYesNo
003NATPARAPARATHYROID HORMONEINJECTABLE;INJECTION75MCGYesNo
004NATPARAPARATHYROID HORMONEINJECTABLE;INJECTION100MCGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68875-0202NATPARA (parathyroid hormone)PARATHYROID HORMONETakeda Pharmaceuticals America, Inc.BLACurrent
68875-0202NATPARA (parathyroid hormone)PARATHYROID HORMONEShire-NPS Pharmaceuticals, Inc.BLACurrent
68875-0202NATPARA (parathyroid hormone)PARATHYROID HORMONEShire-NPS Pharmaceuticals, Inc.BLACurrent
68875-0202NATPARA (parathyroid hormone)PARATHYROID HORMONEShire-NPS Pharmaceuticals, Inc.BLACurrent
68875-0203NATPARA (parathyroid hormone)PARATHYROID HORMONETakeda Pharmaceuticals America, Inc.BLACurrent
68875-0203NATPARA (parathyroid hormone)PARATHYROID HORMONEShire-NPS Pharmaceuticals, Inc.BLACurrent
68875-0203NATPARA (parathyroid hormone)PARATHYROID HORMONEShire-NPS Pharmaceuticals, Inc.BLACurrent
68875-0203NATPARA (parathyroid hormone)PARATHYROID HORMONEShire-NPS Pharmaceuticals, Inc.BLACurrent
68875-0204NATPARA (parathyroid hormone)PARATHYROID HORMONETakeda Pharmaceuticals America, Inc.BLACurrent
68875-0204NATPARA (parathyroid hormone)PARATHYROID HORMONEShire-NPS Pharmaceuticals, Inc.BLACurrent
68875-0204NATPARA (parathyroid hormone)PARATHYROID HORMONEShire-NPS Pharmaceuticals, Inc.BLACurrent
68875-0204NATPARA (parathyroid hormone)PARATHYROID HORMONEShire-NPS Pharmaceuticals, Inc.BLACurrent
68875-0205NATPARA (parathyroid hormone)PARATHYROID HORMONETakeda Pharmaceuticals America, Inc.BLACurrent
68875-0205NATPARA (parathyroid hormone)PARATHYROID HORMONEShire-NPS Pharmaceuticals, Inc.BLACurrent
68875-0205NATPARA (parathyroid hormone)PARATHYROID HORMONEShire-NPS Pharmaceuticals, Inc.BLACurrent
68875-0205NATPARA (parathyroid hormone)PARATHYROID HORMONEShire-NPS Pharmaceuticals, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70745SUPPL2022-04-11
70735SUPPL2022-04-08
63792SUPPL2020-07-06
63780SUPPL2020-07-02
63456SUPPL2020-06-09
56919SUPPL2018-12-21
56781SUPPL2018-12-18
56780SUPPL2018-12-18
55813SUPPL2018-10-04
55812SUPPL2018-10-04
55751SUPPL2018-10-01
52750ORIG2018-02-28
45457SUPPL2016-10-03
31987SUPPL2016-06-21
39981SUPPL2016-06-17
44812ORIG2015-02-19
22817ORIG2015-02-19
18928ORIG2015-01-29
44568ORIG2015-01-28
31986ORIG2015-01-26