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Daytrana

NDA 21514, held by Noven Pharms Inc. Methylphenidate.

  • First approved: Apr 6, 2006
  • Review: Standard
  • Supplements approved: 26
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below
DateSubmissionStatusDocuments
Jun 29, 2010Supplement 10Efficacy (new indication or use) · Standard reviewApprovedLabelLetter
Apr 6, 2006Original applicationTYPE 2/3 · Standard reviewApprovedReviewLetterPediatric Medical ReviewPediatric Clinical Pharmacology Review

Products

4 strengths and forms
ProductActive ingredientMarketing
Daytrana10MG/9HR (1.1MG/HR) · film, extended release;transdermalMethylphenidateRx · reference drug
Daytrana15MG/9HR (1.6MG/HR) · film, extended release;transdermalMethylphenidateRx · reference drug
Daytrana20MG/9HR (2.2MG/HR) · film, extended release;transdermalMethylphenidateRx · reference drug
Daytrana30MG/9HR (3.3MG/HR) · film, extended release;transdermalMethylphenidateRx · reference drug
All 27 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Sep 23, 2025Supplement 43Labeling · Standard reviewApprovedLetterLabelMedication Guide
Nov 29, 2024Supplement 39Labeling · Standard reviewApprovedLabelLetter
Oct 13, 2023Supplement 36Labeling · Standard reviewApprovedLabelLetter
Jun 25, 2021Supplement 32LabelingApprovedLetterLabel
Oct 22, 2019Supplement 30Labeling · Standard reviewApprovedLabelLetter
Nov 6, 2017Supplement 28Labeling · Standard reviewApprovedLabelLetter
Jan 4, 2017Supplement 25LabelingApprovedLetterLabel
Aug 19, 2016Supplement 24Labeling · Standard reviewApprovedLabelLetter
Nov 9, 2015Supplement 18Manufacturing · Standard reviewApprovedNone posted
Aug 14, 2015Supplement 23LabelingApprovedReviewLetterLabel
Apr 17, 2015Supplement 22LabelingApprovedLabelLetter
Apr 14, 2015Supplement 20Manufacturing · Standard reviewApprovedNone posted
Apr 14, 2015Supplement 21Manufacturing · Standard reviewApprovedNone posted
Dec 12, 2013Supplement 17Labeling · Standard reviewApprovedReviewLabelLetter
Jun 6, 2013Supplement 15Labeling · Standard reviewApprovedLetterLabel
May 9, 2013Supplement 16Manufacturing · Standard reviewApprovedNone posted
Nov 21, 2012Supplement 14Manufacturing · Standard reviewApprovedNone posted
Oct 18, 2010Supplement 11LabelingApprovedLetterLabel
Jun 29, 2010Supplement 9Labeling · Standard reviewApprovedLetter
Jun 29, 2010Supplement 10Efficacy (new indication or use) · Standard reviewApprovedLabelLetter
Dec 15, 2009Supplement 8Labeling · Standard reviewApprovedLetterLabel
Feb 5, 2008Supplement 3Labeling · Standard reviewApprovedLabel
Feb 5, 2008Supplement 6Labeling · Standard reviewApprovedLabel
Feb 5, 2008Supplement 7Labeling · Standard reviewApprovedLabel
May 1, 2007Supplement 5Labeling · Standard reviewApprovedLetterLabel
Jul 27, 2006Supplement 1Labeling · Standard reviewApprovedLetterLabel
Apr 6, 2006Original applicationTYPE 2/3 · Standard reviewApprovedReviewLetterPediatric Medical ReviewPediatric Clinical Pharmacology Review

Identifiers

Application
NDA 21514

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters

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