Application 208743

Type
NDA
Sponsor
RADIUS HEALTH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TYMLOSABALOPARATIDESOLUTION;SUBCUTANEOUS3.12MG/1.56ML (2MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70539-001TymlosabaloparatideRadius Health, Inc.NDACurrent
70539-001TymlosabaloparatideRadius Health, Inc.NDACurrent
70539-001TymlosabaloparatideRadius Health, Inc.NDACurrent
70539-001TymlosabaloparatideRadius Health, Inc.NDACurrent
70539-001TymlosabaloparatideRadius Health, Inc.NDACurrent
70539-001TymlosabaloparatideRadius Health, Inc.NDACurrent
70539-001TymlosabaloparatideRadius Health, Inc.NDACurrent
70539-001TymlosabaloparatideRadius Health, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84393SUPPL 2026-03-02
81894SUPPL 2025-04-09
81817SUPPL 2025-04-03
77142SUPPL 2023-12-27
77113SUPPL 2023-12-27
72968SUPPL2022-12-21
72967SUPPL2022-12-21
69754SUPPL2021-12-23
69160SUPPL2021-10-29
68695SUPPL2021-09-21
68682SUPPL2021-09-21
68681SUPPL2021-09-21
65038SUPPL2020-10-27
65037SUPPL2020-10-27
65033SUPPL2020-10-27
56059SUPPL2018-10-23
56014SUPPL2018-10-18
54745SUPPL2018-07-04
54704SUPPL2018-06-27
52539SUPPL2018-02-09
52396SUPPL2018-02-05
48681ORIG2017-06-08
48680ORIG2017-06-08
48159ORIG2017-04-28
48158ORIG2017-04-28
48157ORIG2017-04-28