Details for New Drug Application (NDA): 209905
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The generic ingredient in EVEKEO ODT is amphetamine sulfate. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
Summary for 209905
| Tradename: | EVEKEO ODT |
| Applicant: | Azurity |
| Ingredient: | amphetamine sulfate |
| Patents: | 3 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 30, 2019 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Mar 10, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Mar 10, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Mar 10, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS | ||||||||
Expired US Patents for NDA 209905
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Azurity | EVEKEO ODT | amphetamine sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 209905-003 | Jan 30, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| Azurity | EVEKEO ODT | amphetamine sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 209905-005 | Apr 16, 2021 | ⤷ Start Trial | ⤷ Start Trial |
| Azurity | EVEKEO ODT | amphetamine sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 209905-004 | Jan 30, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| Azurity | EVEKEO ODT | amphetamine sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 209905-001 | Jan 30, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| Azurity | EVEKEO ODT | amphetamine sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 209905-002 | Jan 30, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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