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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022063
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYDAYIS AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125MG;3.125MG;3.125MG;3.125MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
MYDAYIS AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
MYDAYIS AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 9.375MG;9.375MG;9.375MG;9.375MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
MYDAYIS AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 12.5MG;12.5MG;12.5MG;12.5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/20/2017 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022063s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022063Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/022063Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/25/2022 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022063s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021303Orig1s036; 021977Orig1s048; 022063Orig1s003; 208510Orig1s005ltr.pdf
09/13/2019 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022063s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022063Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/25/2022 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022063s003lbl.pdf
02/25/2022 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022063s003lbl.pdf
09/13/2019 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022063s001lbl.pdf
06/20/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022063s000lbl.pdf
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