Assyro AI

Orange Book product · Brand (NDA)

MYDAYIS

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Brand (NDA)NDA 022063TE AB2RX TAKEDA PHARMS USA
View AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE familyOpen on FDA Orange Book

At a glance

Jun 20, 2017

Approved

Brand (NDA)

Application

AB2

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 20, 2017

    9 yr 2 mo ago

  2. Patent 9173857 expires

    Listed method-of-use patent (U-2025) expiration.

    May 12, 2026

    1 mo ago

  3. Today

  4. Patent 8846100 expires

    Listed drug product patent expiration.

    Aug 24, 2029

    in 3 yr 3 mo

Pharmaceutical detail

Active ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Strength

9.375MG;9.375MG;9.375MG;9.375MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

AB2

Application

NDA 022063

Product number

003

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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 (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9173857May 12, 20261 mo ago
U-2025
8846100Aug 24, 2029in 3 yr 3 mo
Product
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo