Details for New Drug Application (NDA): 204326
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The generic ingredient in ADZENYS XR-ODT 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 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 | Neos Therapeutics Brands, LLC | 70165-005 | 70165-005-30 | 30 BLISTER PACK in 1 CARTON (70165-005-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326 | NDA | Neos Therapeutics Brands, LLC | 70165-010 | 70165-010-30 | 30 BLISTER PACK in 1 CARTON (70165-010-30) / 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: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 28, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 9, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 28, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? |
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