NDC 63020-040

EXKIVITY

Mobocertinib

EXKIVITY is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Mobocertinib.

Product ID63020-040_46bccc44-788b-444f-a47d-8b6e8f81d30b
NDC63020-040
Product TypeHuman Prescription Drug
Proprietary NameEXKIVITY
Generic NameMobocertinib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2021-09-15
Marketing CategoryNDA /
Application NumberNDA215310
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NameMOBOCERTINIB
Active Ingredient Strength40 mg/1
Pharm ClassesCytochrome P450 3A Inducers [MoA], HER1 Antagonists [MoA], Kinase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63020-040-12

120 CAPSULE in 1 BOTTLE (63020-040-12)
Marketing Start Date2021-09-15
NDC Exclude FlagN
Sample Package?N

Drug Details


Trademark Results [EXKIVITY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXKIVITY
EXKIVITY
90046914 not registered Live/Pending
Takeda Pharmaceuticals International AG
2020-07-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.