Orange Book product · Brand (NDA)

DAYTRANA

METHYLPHENIDATE

Brand (NDA)NDA 021514TE ABRX NOVEN PHARMS INC

View METHYLPHENIDATE family Open on FDA Orange Book

At a glance

Apr 06, 2006

Approved

Brand (NDA)

Application

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Apr 06, 2006
20 yr 6 mo ago
Today

Pharmaceutical detail

Active ingredient

METHYLPHENIDATE

Strength

10MG/9HR (1.1MG/HR)

Dosage form

FILM, EXTENDED RELEASE

Route

TRANSDERMAL

TE code

Application

NDA 021514

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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