Details for New Drug Application (NDA): 204325
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NDA 204325 describes ADZENYS ER, which is a drug marketed by Neos Theraps Inc and is included in one NDA. There are three patents protecting this drug. Additional details are available on the ADZENYS ER profile page.
The generic ingredient in ADZENYS ER is amphetamine. There are fifty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amphetamine profile page.
The generic ingredient in ADZENYS ER is amphetamine. There are fifty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amphetamine profile page.
Summary for 204325
| Tradename: | ADZENYS ER |
| Applicant: | Neos Theraps Inc |
| Ingredient: | amphetamine |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 204325
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION, EXTENDED RELEASE;ORAL | Strength | EQ 1.25MG BASE/ML | ||||
| Approval Date: | Sep 15, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 28, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 28, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 28, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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