Details for New Drug Application (NDA): 021514

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NDA 021514 describes DAYTRANA, which is a drug marketed by Noven Pharms Inc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DAYTRANA profile page.

The generic ingredient in DAYTRANA is methylphenidate. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methylphenidate profile page.

Summary for 021514

Tradename:	DAYTRANA
Applicant:	Noven Pharms Inc
Ingredient:	methylphenidate
Patents:	3

Pharmacology for NDA: 021514

Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for 021514

Central Nervous System Stimulants
Dopamine Uptake Inhibitors

Suppliers and Packaging for NDA: 021514

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514	NDA AUTHORIZED GENERIC	PADAGIS US LLC	0574-2410	0574-2410-65	1 TRAY in 1 CARTON (0574-2410-65) / 30 POUCH in 1 TRAY / 1 PATCH in 1 POUCH / 27.5 mg in 1 PATCH
DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514	NDA AUTHORIZED GENERIC	PADAGIS US LLC	0574-2415	0574-2415-65	1 TRAY in 1 CARTON (0574-2415-65) / 30 POUCH in 1 TRAY / 1 PATCH in 1 POUCH / 41.3 mg in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	10MG/9HR (1.1MG/HR)
Approval Date:	Apr 6, 2006	TE:	AB	RLD:	Yes
Patent:	8,632,802	Patent Expiration:	Oct 7, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	9,034,370	Patent Expiration:	Oct 7, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	9,668,981	Patent Expiration:	Oct 7, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF

Expired US Patents for NDA 021514

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-002	Apr 6, 2006	5,958,446	⤷ Subscribe
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-001	Apr 6, 2006	5,958,446	⤷ Subscribe
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006	5,958,446	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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