Details for New Drug Application (NDA): 204326
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NDA 204326 describes ADZENYS XR-ODT, which is a drug marketed by Neos Theraps and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the ADZENYS XR-ODT profile page.
The generic ingredient in ADZENYS XR-ODT is amphetamine. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the amphetamine profile page.
The generic ingredient in ADZENYS XR-ODT is amphetamine. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the amphetamine profile page.
Summary for 204326
| Tradename: | ADZENYS XR-ODT |
| Applicant: | Neos Theraps |
| Ingredient: | amphetamine |
| Patents: | 5 |
Pharmacology for NDA: 204326
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 204326
Suppliers and Packaging for NDA: 204326
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326 | NDA AUTHORIZED GENERIC | Neos Therapeutics, LP | 62542-005 | 62542-005-30 | 30 BLISTER PACK in 1 CARTON (62542-005-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326 | NDA AUTHORIZED GENERIC | Neos Therapeutics, LP | 62542-010 | 62542-010-30 | 30 BLISTER PACK in 1 CARTON (62542-010-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Strength | EQ 3.1MG BASE | ||||
| Approval Date: | Jan 27, 2016 | TE: | AB | RLD: | Yes | ||||
| Patent: | 8,709,491 | Patent Expiration: | Jun 28, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,840,924 | Patent Expiration: | Apr 9, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 9,017,731 | Patent Expiration: | Jun 28, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 204326
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-005 | Jan 27, 2016 | 8,840,924 | ⤷ Start Trial |
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-001 | Jan 27, 2016 | 8,840,924 | ⤷ Start Trial |
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-006 | Jan 27, 2016 | 8,840,924 | ⤷ Start Trial |
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-003 | Jan 27, 2016 | 8,840,924 | ⤷ Start Trial |
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-002 | Jan 27, 2016 | 8,840,924 | ⤷ Start Trial |
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-004 | Jan 27, 2016 | 8,840,924 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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