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DYANAVEL XR

amphetamine · Tablet, Extended Release

Prescription NDA Schedule CII RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
DYANAVEL XR
Generic name
amphetamine
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
NextWave Pharmaceuticals, Inc
Product type
Human Prescription Drug
DEA schedule
CII
Active ingredients
4
NDC product codes
4
Packages
4
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Amphetamine 10 mg/1 1739803 View
Amphetamine 15 mg/1 1739803 View
Amphetamine 20 mg/1 1739803 View
Amphetamine 5 mg/1 1739803 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Extended Release
Route of administration
Oral
Presentations
8

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Central Nervous System Stimulant [EPC] EPC All 93 members
Central Nervous System Stimulation [PE] PE All 95 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
210526
Application type
NDA · New Drug Application
Approval date
November 4, 2021
Sponsor
TRIS PHARMA INC
Products on application
4
Submissions recorded
6
Products approved under application 210526.
Product Trade name Form Strength Ingredient Status TE Flags
210526-001 DYANAVEL XR 5 TABLET, EXTENDED RELEASE AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE Prescription — RLD
210526-002 DYANAVEL XR 10 TABLET, EXTENDED RELEASE AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE Prescription — RLD
210526-003 DYANAVEL XR 15 TABLET, EXTENDED RELEASE AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE Prescription — RLD
210526-004 DYANAVEL XR 20 TABLET, EXTENDED RELEASE AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9675704 March 15, 2027 001 No November 22, 2021
8337890 March 15, 2027 001 No November 22, 2021
8747902 March 15, 2027 001 No November 22, 2021
8337890 March 15, 2027 002 No November 22, 2021
8747902 March 15, 2027 002 No November 22, 2021
9675704 March 15, 2027 002 No November 22, 2021
8747902 March 15, 2027 003 No November 22, 2021
9675704 March 15, 2027 003 No November 22, 2021
8337890 March 15, 2027 003 No November 22, 2021
9675704 March 15, 2027 004 No November 22, 2021
8337890 March 15, 2027 004 No November 22, 2021
8747902 March 15, 2027 004 No November 22, 2021
11590081 September 24, 2038 001 No U-3538 March 8, 2023
11590081 September 24, 2038 002 No U-3538 March 8, 2023
11590081 September 24, 2038 003 No U-3538 March 8, 2023
11590081 September 24, 2038 004 No U-3538 March 8, 2023
12458592 February 11, 2040 001 No U-3538 November 14, 2025
12458592 February 11, 2040 002 No U-3538 November 14, 2025
12458592 February 11, 2040 003 No U-3538 November 14, 2025
12458592 February 11, 2040 004 No U-3538 November 14, 2025

Approval history

Source: Drugs@FDA
Most recent submissions on application 210526.
Type No. Action Status Date Review
Supplement 10 Labeling Approved September 23, 2025 Standard
Supplement 8 Labeling Approved October 13, 2023 Standard
Supplement 2 Labeling Approved October 14, 2022 Standard
Supplement 1 Labeling Approved June 1, 2022 Standard
Supplement 3 Labeling Approved February 25, 2022 901 Required
Original application 1 Type 3 - New Dosage Form Approved November 4, 2021 Standard

Review documents

  • 0 · Supplement · September 25, 2025
  • 0 · Supplement · September 25, 2025
  • 0 · Supplement · September 25, 2025
  • 0 · Supplement · October 17, 2023
  • 0 · Supplement · October 16, 2023
  • 0 · Supplement · October 17, 2022
  • 0 · Supplement · June 6, 2022
  • 0 · Supplement · June 2, 2022
  • 0 · Original application · March 21, 2022
  • 0 · Supplement · March 2, 2022
  • 0 · Supplement · February 28, 2022
  • 0 · Original application · November 8, 2021
  • 0 · Original application · November 8, 2021

Adverse event reports

Source: openFDA FAERS
50,216
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: AMPHETAMINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
24478-106-01 24478-106 NextWave Pharmaceuticals, Inc 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01) August 1, 2022
24478-108-01 24478-108 NextWave Pharmaceuticals, Inc 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-108-01) August 1, 2022
24478-109-01 24478-109 NextWave Pharmaceuticals, Inc 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-109-01) August 1, 2022
24478-110-01 24478-110 NextWave Pharmaceuticals, Inc 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-110-01) August 1, 2022
24478-106 24478-106 NextWave Pharmaceuticals, Inc — November 4, 2021
24478-108 24478-108 NextWave Pharmaceuticals, Inc — November 4, 2021
24478-109 24478-109 NextWave Pharmaceuticals, Inc — November 4, 2021
24478-110 24478-110 NextWave Pharmaceuticals, Inc — November 4, 2021

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.