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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 one supplier. There are four 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-one drug master file entries for this compound. One supplier is listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the methylphenidate profile page.

Summary for NDA: 021514

Tradename:
DAYTRANA
Applicant:
Noven Pharms Inc
Ingredient:
methylphenidate
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 Noven Therapeutics, LLC 68968-5552 68968-5552-3 30 PATCH in 1 CARTON (68968-5552-3) > 9 h in 1 PATCH
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL 021514 NDA Noven Therapeutics, LLC 68968-5553 68968-5553-3 30 PATCH in 1 CARTON (68968-5553-3) > 9 h in 1 PATCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength10MG/9HR (1.1MG/HR)
Approval Date:Apr 6, 2006TE:RLD:No
Patent:8,632,802Patent Expiration:Oct 7, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:9,034,370Patent Expiration:Oct 7, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:6,210,705Patent Expiration:Sep 30, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

Expired Orange Book Patents for NDA: 021514

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-001Apr 6, 20065,958,446► subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-002Apr 6, 20065,958,446► subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-004Apr 6, 20065,958,446► subscribe
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