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Medicines · US (FDA)

FDA 2016

FDA

Dextroamphetamine Saccharate; Amphetamine Aspartate Monohydrate; Dextroamphetamine Sulfate; Amphetamine Sulfate

Approved 15 Apr 2016OralCapsule, extended release

The FDA lists this product in 6 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: DEXTROAMPHETAMINE SACCHARATE 25MG; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

DEXTROAMPHETAMINE SACCHARATE 15MG; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE · Capsule, extended releaseANDA206304-003 · Tentative approval
DEXTROAMPHETAMINE SACCHARATE 5MG; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE · Capsule, extended releaseANDA206304-001 · Tentative approval
DEXTROAMPHETAMINE SACCHARATE 30MG; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE · Capsule, extended releaseANDA206304-006 · Tentative approval
DEXTROAMPHETAMINE SACCHARATE 20MG; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE · Capsule, extended release

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA206304-004 · Tentative approval

DEXTROAMPHETAMINE SACCHARATE 10MG; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE · Capsule, extended releaseANDA206304-002 · Tentative approval

DEXTROAMPHETAMINE SACCHARATE 25MG; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE · Capsule, extended releaseThis page

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA206304.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Dextroamphetamine Saccharate; Amphetamine Aspartate Monohydrate; Dextroamphetamine Sulfate; Amphetamine Sulfate
Active substance: dextroamphetamine saccharate
Route: Oral
Dosage form: Capsule, extended release
Applicant: Corepharma
Status: Tentative approval
FDA approval: 15 Apr 2016
Application: ANDA206304-005