FDA.reportPublic FDA data

Application 210238

Type
NDA
Sponsor
AKARX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOPTELETAVATROMBOPAG MALEATETABLET;ORALEQ 20MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71369-020DOPTELETavatrombopag maleateAkaRx, Inc.NDACurrent
71369-020DOPTELETavatrombopag maleateAkaRx, Inc.NDACurrent
71369-020DOPTELETavatrombopag maleateAkaRx, Inc.NDACurrent
71369-020DOPTELETavatrombopag maleateAkaRx, Inc.NDACurrent
71369-020DOPTELETavatrombopag maleateAkaRx, Inc.NDACurrent
71369-020DOPTELETavatrombopag maleateAkaRx, Inc.NDACurrent
71369-020DOPTELETavatrombopag maleateAkaRx, Inc.NDACurrent
71369-020DOPTELETavatrombopag maleateAkaRx, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82962SUPPL 2026-05-12
82941SUPPL 2025-07-25
79147SUPPL 2024-07-22
79130SUPPL 2024-07-22
69024SUPPL2021-10-19
68999SUPPL2021-10-15
64378SUPPL2020-08-24
64345SUPPL2020-08-21
59193SUPPL2019-06-28
59187SUPPL2019-06-20
58066SUPPL2019-03-22
54724ORIG2018-06-28
54319ORIG2018-05-24
54258ORIG2018-05-21