← FDA Drug Approvals (Drugs@FDA)
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
- Machine
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