FDA.reportPublic FDA data

Application 208385

Type
NDA
Sponsor
SAGENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAPTOMYCINDAPTOMYCINPOWDER;IV (INFUSION)350MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-179DaptomycinDaptomycinSagent PharmaceuticalsNDACurrent
25021-179DaptomycinDaptomycinSagent PharmaceuticalsNDACurrent
25021-179DaptomycinDaptomycinSagent PharmaceuticalsNDACurrent
25021-179DaptomycinDaptomycinSagent PharmaceuticalsNDACurrent
25021-179DaptomycinDaptomycinSagent PharmaceuticalsNDACurrent
25021-179DaptomycinDaptomycinSagent PharmaceuticalsNDACurrent
25021-179DaptomycinDaptomycinSagent PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82143SUPPL 2025-05-05
82289SUPPL 2025-04-30
70141SUPPL2022-02-10
70140SUPPL2022-02-10
70124SUPPL2022-02-08
70123SUPPL2022-02-08
62516SUPPL2020-04-09
62446SUPPL2020-04-06
55468SUPPL2018-09-13
55377SUPPL2018-08-31
54473ORIG2018-06-07
50517ORIG2017-11-28
49753ORIG2017-09-15