Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate

ANDA 40422, held by Barr. Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate.

First approved: Feb 11, 2002
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Feb 11, 2002	Original application	Approved	Review

Products

7 strengths and forms

Product	Active ingredient	Marketing
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate1.25MG;1.25MG;1.25MG;1.25MG · tablet;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	Rx
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate2.5MG;2.5MG;2.5MG;2.5MG · tablet;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	Rx
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate5MG;5MG;5MG;5MG · tablet;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	Rx
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate7.5MG;7.5MG;7.5MG;7.5MG · tablet;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	Rx
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate1.875MG;1.875MG;1.875MG;1.875MG · tablet;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	Rx
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate3.125MG;3.125MG;3.125MG;3.125MG · tablet;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	Rx
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate3.75MG;3.75MG;3.75MG;3.75MG · tablet;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	Rx

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 13, 2023	Supplement 59Labeling · Standard review	Approved	None posted
Mar 7, 2023	Supplement 58Labeling · Standard review	Approved	None posted
Feb 25, 2022	Supplement 57Labeling · Standard review	Approved	None posted
Feb 14, 2022	Supplement 56Labeling · Standard review	Approved	None posted
Jan 4, 2017	Supplement 44Labeling · Standard review	Approved	None posted
Sep 27, 2016	Supplement 42Labeling · Standard review	Approved	None posted
Oct 23, 2015	Supplement 20Labeling	Approved	None posted
Apr 17, 2015	Supplement 38Labeling · Standard review	Approved	Letter Label
Jun 10, 2014	Supplement 36Labeling · Standard review	Approved	Letter Label
Feb 13, 2014	Supplement 34Labeling · Standard review	Approved	Letter Label
Feb 13, 2014	Supplement 33Labeling · Standard review	Approved	Letter Label
Sep 25, 2013	Supplement 30Labeling · Standard review	Approved	Label
Mar 27, 2012	Supplement 26Labeling	Approved	None posted
Aug 11, 2009	Supplement 22Labeling	Approved	None posted
Aug 11, 2008	Supplement 24Labeling	Approved	None posted
Mar 19, 2003	Supplement 6Labeling	Approved	None posted
Sep 11, 2002	Supplement 1Manufacturing	Approved	None posted
Feb 11, 2002	Original application	Approved	Review

Identifiers

Application: ANDA 40422
Drugs@FDA: Overview at FDA
Company: Barr Laboratories

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