Adderall 10, Adderall 20, Adderall 5

NDA 11522, held by Teva Womens. Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate.

As of Nov 14, 2026, NDA 11522 (Adderall 10, Adderall 20, Adderall 5), held by Teva Womens, was first approved by FDA on Jan 19, 1960, with 32 approved supplements and 0 published complete response letters.

First approved: Jan 19, 1960
Review: Standard
Supplements approved: 32
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
Jan 19, 1960	Original applicationTYPE 2/4 · Standard review	Approved	None posted

Products

7 strengths and forms


Adderall 102.5MG;2.5MG;2.5MG;2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	DiscontinuedReference drug
Adderall 205MG;5MG;5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	DiscontinuedReference drug
Adderall 51.25MG;1.25MG;1.25MG;1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	DiscontinuedReference drug
Adderall 307.5MG;7.5MG;7.5MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	DiscontinuedReference drug
Adderall 7.51.875MG;1.875MG;1.875MG;1.875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	DiscontinuedReference drug
Adderall 12.53.125MG;3.125MG;3.125MG;3.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	DiscontinuedReference drug
Adderall 153.75MG;3.75MG;3.75MG;3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	DiscontinuedReference drug

All 33 submissions, including labeling and manufacturing supplements


Oct 13, 2023	Supplement 45Labeling · Standard review	Approved	Label Medication Guide Letter
Feb 25, 2022	Supplement 44Labeling	Approved	Label Letter
Jan 4, 2017	Supplement 43Labeling	Approved	Letter Label
Oct 1, 2015	Supplement 42Labeling · Standard review	Approved	Label Letter
Apr 17, 2015	Supplement 41Labeling	Approved	Letter Label
Jun 7, 2007	Supplement 40Labeling · Standard review	Approved	Letter Label
Jul 26, 2006	Supplement 37Labeling · Standard review	Approved	Letter Label
Jul 26, 2006	Supplement 34Labeling · Standard review	Approved	Letter Label
Aug 2, 2005	Supplement 33Labeling · Standard review	Approved	Letter Label
Aug 2, 2005	Supplement 32Labeling · Standard review	Approved	Letter Label
Nov 8, 2002	Supplement 30Manufacturing · Standard review	Approved	Review Letter
Apr 11, 2002	Supplement 29Manufacturing · Standard review	Approved	None posted
Dec 10, 2001	Supplement 28Manufacturing · Standard review	Approved	None posted
Aug 31, 2000	Supplement 26Manufacturing · Standard review	Approved	None posted
Jul 24, 2000	Supplement 27Manufacturing · Standard review	Approved	None posted
Feb 15, 2000	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 26, 2000	Supplement 24Manufacturing · Standard review	Approved	None posted
Nov 12, 1999	Supplement 22Manufacturing · Standard review	Approved	None posted
Sep 20, 1999	Supplement 23Manufacturing · Standard review	Approved	None posted
May 21, 1999	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 23, 1999	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 16, 1998	Supplement 19Manufacturing · Standard review	Approved	None posted
Jan 8, 1998	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 14, 1997	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 25, 1997	Supplement 17Labeling · Standard review	Approved	None posted
Jul 17, 1997	Supplement 15Labeling · Standard review	Approved	None posted
Jul 17, 1997	Supplement 11Labeling · Standard review	Approved	None posted
Jun 13, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
May 12, 1997	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 29, 1997	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 13, 1996	Supplement 10Manufacturing · Standard review	Approved	Review
Feb 13, 1996	Supplement 9Labeling	Approved	None posted
Jan 19, 1960	Original applicationTYPE 2/4 · Standard review	Approved	None posted

Identifiers

Application: NDA 11522
Drugs@FDA: Overview at FDA
Company: Teva Women's Health

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