Dextroamphetamine Sulfate

ANDA 205673, held by Strides Pharma Intl. Dextroamphetamine Sulfate.

As of Nov 15, 2026, ANDA 205673 (Dextroamphetamine Sulfate), held by Strides Pharma Intl, was first approved by FDA on Oct 31, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 31, 2017
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 31, 2017	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 3 submissions, including labeling and manufacturing supplements


Mar 11, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Mar 11, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Oct 31, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 205673
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

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