Application 211939

Type
NDA
Sponsor
ALVOGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BONSITYTERIPARATIDESOLUTION;SUBCUTANEOUS0.62MG/2.48ML (0.25MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-652teriparatideteriparatideAlvogen, Inc.NDACurrent
47781-652teriparatideteriparatideAlvogen, Inc.NDACurrent
47781-652teriparatideteriparatideAlvogen, Inc.NDACurrent
47781-652teriparatideteriparatideAlvogen, Inc.NDACurrent
47781-652teriparatideteriparatideAlvogen, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81092SUPPL 2025-02-06
81035SUPPL 2025-02-06
76618SUPPL 2023-11-17
76604SUPPL 2023-11-17
76603SUPPL 2023-11-17
61966ORIG2020-02-26
60263ORIG2019-10-07
60250ORIG2019-10-07
60249ORIG2019-10-07