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Accenture
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Fuji
Federal Trade Commission
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Generated: October 20, 2017

DrugPatentWatch Database Preview

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-three 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:
1
Applicant:
1
Ingredient:
1
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:Yes
Patent:► SubscribePatent Expiration:Jun 28, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Apr 9, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Jun 28, 2032Product Flag?YSubstance Flag?Delist Request?


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Serving leading biopharmaceutical companies globally:

Dow
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US Army
Express Scripts
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