Details for New Drug Application (NDA): 209905

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NDA 209905 describes EVEKEO ODT, which is a drug marketed by Azurity and is included in one NDA. There are three patents protecting this drug. Additional details are available on the EVEKEO ODT profile page.

The generic ingredient in EVEKEO ODT is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.

Summary for 209905

Tradename:	EVEKEO ODT
Applicant:	Azurity
Ingredient:	amphetamine sulfate
Patents:	3

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	5MG
Approval Date:	Jan 30, 2019	TE:		RLD:	Yes
Patent:	⤷ Try for Free	Patent Expiration:	Mar 10, 2037	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try for Free	Patent Expiration:	Mar 10, 2037	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try for Free	Patent Expiration:	Mar 10, 2037	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS

Expired US Patents for NDA 209905

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-002	Jan 30, 2019	⤷ Try for Free	⤷ Try for Free
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-005	Apr 16, 2021	⤷ Try for Free	⤷ Try for Free
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-001	Jan 30, 2019	⤷ Try for Free	⤷ Try for Free
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-003	Jan 30, 2019	⤷ Try for Free	⤷ Try for Free
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-004	Jan 30, 2019	⤷ Try for Free	⤷ Try for Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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