FDA approval · Drugs@FDA
MYDAYISamphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate
NDA022063 ·
FDA approved the original new drug application for MYDAYIS on June 20, 2017, sponsored by TAKEDA PHARMS USA. FDA has approved 1 efficacy supplement on the application since, the most recent on September 13, 2019.
- Application
- NDA022063
- Sponsor
- TAKEDA PHARMS USA
- Original approval
- Review
- standard review
- Submission class
- Type 3 - New Dosage Form
- Active ingredient
- amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate
Browse every approval whose brand starts with M, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| amphetamine aspartate 9.375MG; amphetamine sulfate 9.375MG; dextroamphetamine saccharate 9.375MG; dextroamphetamine sulfate 9.375MG | CAPSULE, EXTENDED RELEASE | ORAL | Prescription |
| amphetamine aspartate 3.125MG; amphetamine sulfate 3.125MG; dextroamphetamine saccharate 3.125MG; dextroamphetamine sulfate 3.125MG | CAPSULE, EXTENDED RELEASE | ORAL | Prescription |
| amphetamine aspartate 12.5MG; amphetamine sulfate 12.5MG; dextroamphetamine saccharate 12.5MG; dextroamphetamine sulfate 12.5MG | CAPSULE, EXTENDED RELEASE | ORAL | Prescription |
| amphetamine aspartate 6.25MG; amphetamine sulfate 6.25MG; dextroamphetamine saccharate 6.25MG; dextroamphetamine sulfate 6.25MG | CAPSULE, EXTENDED RELEASE | ORAL | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-1 | priority |
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 3. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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