Dexedrine Spansule

NDA 17078, held by Impax Labs Inc. Dextroamphetamine Sulfate.

As of Nov 13, 2026, NDA 17078 (Dexedrine Spansule), held by Impax Labs Inc, was first approved by FDA on Aug 2, 1976, with 40 approved supplements and 0 published complete response letters.

First approved: Aug 2, 1976
Review: Standard
Supplements approved: 40
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Dextroamphetamine sulfate is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 41 submissions below

Date	Submission	Status	Documents
Aug 2, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms


Dexedrine Spansule5MG · capsule, extended release;oral	Dextroamphetamine Sulfate	RxReference drug
Dexedrine Spansule10MG · capsule, extended release;oral	Dextroamphetamine Sulfate	RxReference drug
Dexedrine Spansule15MG · capsule, extended release;oral	Dextroamphetamine Sulfate	RxReference drug

All 41 submissions, including labeling and manufacturing supplements


Sep 23, 2025	Supplement 59Labeling · Standard review	Approved	Label Medication Guide Letter
Oct 13, 2023	Supplement 55Labeling · Standard review	Approved	Label Letter
Feb 25, 2022	Supplement 54Labeling	Approved	Label Letter
Jan 15, 2019	Supplement 52Labeling · Standard review	Approved	Letter Label
May 19, 2017	Supplement 50Labeling	Approved	Letter Label
Jan 4, 2017	Supplement 49Labeling	Approved	Letter Label
Apr 17, 2015	Supplement 48Labeling	Approved	Label Letter
Dec 6, 2013	Supplement 47Labeling · Standard review	Approved	Label Letter
Jun 11, 2013	Supplement 46Labeling · Standard review	Approved	Label Letter
May 23, 2008	Supplement 44Labeling · Standard review	Approved	Label Letter
May 1, 2007	Supplement 42Labeling · Standard review	Approved	Letter Label
Aug 10, 2006	Supplement 40Labeling · Standard review	Approved	Letter Label
Oct 20, 2000	Supplement 38Manufacturing · Standard review	Approved	None posted
Apr 13, 2000	Supplement 37Manufacturing · Standard review	Approved	None posted
Nov 3, 1999	Supplement 34Labeling · Standard review	Approved	None posted
Oct 7, 1999	Supplement 36Manufacturing · Standard review	Approved	None posted
Oct 7, 1999	Supplement 35Manufacturing · Standard review	Approved	None posted
Dec 3, 1998	Supplement 33Manufacturing · Standard review	Approved	None posted
Jun 12, 1998	Supplement 32Manufacturing · Standard review	Approved	None posted
Apr 6, 1998	Supplement 31Manufacturing · Standard review	Approved	None posted
Apr 6, 1998	Supplement 30Manufacturing · Standard review	Approved	None posted
Jul 9, 1997	Supplement 27Labeling · Standard review	Approved	None posted
Sep 12, 1994	Supplement 25Labeling · Standard review	Approved	None posted
Jul 21, 1993	Supplement 22Labeling	Approved	None posted
Dec 16, 1987	Supplement 21Labeling	Approved	None posted
Dec 2, 1987	Supplement 20Labeling	Approved	None posted
Feb 22, 1983	Supplement 17Labeling	Approved	None posted
Aug 25, 1982	Supplement 19Labeling	Approved	None posted
Aug 25, 1982	Supplement 18Labeling	Approved	None posted
Oct 6, 1980	Supplement 16Labeling	Approved	None posted
Sep 19, 1980	Supplement 15Labeling	Approved	None posted
Aug 29, 1980	Supplement 14Labeling	Approved	None posted
Aug 29, 1980	Supplement 13Labeling	Approved	None posted
Aug 29, 1980	Supplement 12Labeling	Approved	None posted
Apr 16, 1980	Supplement 11Labeling	Approved	None posted
Aug 30, 1979	Supplement 9Labeling	Approved	None posted
Jun 27, 1979	Supplement 8Labeling	Approved	None posted
Jun 6, 1979	Supplement 7Labeling	Approved	None posted
Mar 30, 1979	Supplement 5Labeling	Approved	None posted
Mar 30, 1979	Supplement 3Labeling	Approved	None posted
Aug 2, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17078
Drugs@FDA: Overview at FDA
Company: Impax Laboratories

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