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MYDAYIS

NDA · New Drug Application · Sponsor: TAKEDA PHARMS USA · Approved 2017-06-20

Drug application

FDA Application #
NDA022063
Application type
New Drug Application
Brand name
MYDAYIS
Generic name
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, AND AMPHETAMINE SULFATE
Active ingredients
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
TAKEDA PHARMS USA
Manufacturer
Takeda Pharmaceuticals America, Inc.
First approval
2017-06-20

Source

Authoritative
Drugs@FDA application overview
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