Dextroamphetamine Sulfate

ANDA 206735, held by Quagen. Dextroamphetamine Sulfate.

As of Nov 15, 2026, ANDA 206735 (Dextroamphetamine Sulfate), held by Quagen, was first approved by FDA on Jan 27, 2016, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2016
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jan 27, 2016	Original application	Approved	None posted

Products

3 strengths and forms


Dextroamphetamine Sulfate5MG · capsule, extended release;oral	Dextroamphetamine Sulfate	Discontinued
Dextroamphetamine Sulfate10MG · capsule, extended release;oral	Dextroamphetamine Sulfate	Discontinued
Dextroamphetamine Sulfate15MG · capsule, extended release;oral	Dextroamphetamine Sulfate	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Oct 10, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Oct 10, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Oct 10, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Oct 10, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Jan 27, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 206735
Drugs@FDA: Overview at FDA
Company: Quagen Pharmaceuticals

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