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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 one supplier. There are four 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 are fifty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amphetamine profile page.

Summary for NDA: 204326

Tradename:
ADZENYS XR-ODT
Applicant:
Neos Theraps
Ingredient:
amphetamine
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 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, LP 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, LP 70165-010 70165-010-30 30 BLISTER PACK in 1 CARTON (70165-010-30) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALStrengthEQ 3.1MG BASE
Approval Date:Jan 27, 2016TE:RLD:No
Patent:8,709,491Patent Expiration:Jun 28, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:8,840,924Patent Expiration:Apr 9, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:9,017,731Patent Expiration:Jun 28, 2032Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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