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Last Updated: July 23, 2024

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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021514
Medical Subject Heading (MeSH) Categories for 021514
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:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength10MG/9HR (1.1MG/HR)
Approval Date:Apr 6, 2006TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Oct 7, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Oct 7, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Oct 7, 2025Product 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-004 Apr 6, 2006 ⤷  Sign Up ⤷  Sign Up
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-003 Apr 6, 2006 ⤷  Sign Up ⤷  Sign Up
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-002 Apr 6, 2006 ⤷  Sign Up ⤷  Sign Up
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-001 Apr 6, 2006 ⤷  Sign Up ⤷  Sign Up
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-004 Apr 6, 2006 ⤷  Sign Up ⤷  Sign Up
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-004 Apr 6, 2006 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.