APPLICATION
NDA011522
TYPE
NDA
ORIGINAL APPROVAL
1960-01-19
LATEST ACTION
2023-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ADDERALL 5 · ReferenceDiscontinued
AMPHETAMINE ASPARTATE 1.25MG, AMPHETAMINE SULFATE 1.25MG, DEXTROAMPHETAMINE SACCHARATE 1.25MG, DEXTROAMPHETAMINE SULFATE 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ADDERALL 10 · ReferenceDiscontinued
AMPHETAMINE ASPARTATE 2.5MG, AMPHETAMINE SULFATE 2.5MG, DEXTROAMPHETAMINE SACCHARATE 2.5MG, DEXTROAMPHETAMINE SULFATE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ADDERALL 15 · ReferenceDiscontinued
AMPHETAMINE ASPARTATE 3.75MG, AMPHETAMINE SULFATE 3.75MG, DEXTROAMPHETAMINE SACCHARATE 3.75MG, DEXTROAMPHETAMINE SULFATE 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ADDERALL 7.5 · ReferenceDiscontinued
AMPHETAMINE ASPARTATE 1.875MG, AMPHETAMINE SULFATE 1.875MG, DEXTROAMPHETAMINE SACCHARATE 1.875MG, DEXTROAMPHETAMINE SULFATE 1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ADDERALL 20 · ReferenceDiscontinued
AMPHETAMINE ASPARTATE 5MG, AMPHETAMINE SULFATE 5MG, DEXTROAMPHETAMINE SACCHARATE 5MG, DEXTROAMPHETAMINE SULFATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ADDERALL 12.5 · ReferenceDiscontinued
AMPHETAMINE ASPARTATE 3.125MG, AMPHETAMINE SULFATE 3.125MG, DEXTROAMPHETAMINE SACCHARATE 3.125MG, DEXTROAMPHETAMINE SULFATE 3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ADDERALL 30 · ReferenceDiscontinued
AMPHETAMINE ASPARTATE 7.5MG, AMPHETAMINE SULFATE 7.5MG, DEXTROAMPHETAMINE SACCHARATE 7.5MG, DEXTROAMPHETAMINE SULFATE 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-04-11Manufacturing (CMC) · Supplement 29 · standardAP
2001-12-10Manufacturing (CMC) · Supplement 28 · standardAP
2000-08-31Manufacturing (CMC) · Supplement 26 · standardAP
2000-07-24Manufacturing (CMC) · Supplement 27 · standardAP
2000-02-15Manufacturing (CMC) · Supplement 25 · standardAP
2000-01-26Manufacturing (CMC) · Supplement 24 · standardAP
1999-11-12Manufacturing (CMC) · Supplement 22 · standardAP
1999-09-20Manufacturing (CMC) · Supplement 23 · standardAP
1999-05-21Manufacturing (CMC) · Supplement 21 · standardAP
1999-02-23Manufacturing (CMC) · Supplement 20 · standardAP
1998-03-16Manufacturing (CMC) · Supplement 19 · standardAP
1998-01-08Manufacturing (CMC) · Supplement 18 · standardAP
1997-11-14Manufacturing (CMC) · Supplement 16 · standardAP
1997-07-25Labeling · Supplement 17 · standardAP
1997-07-17Labeling · Supplement 15 · standardAP
1997-07-17Labeling · Supplement 11 · standardAP
1997-06-13Manufacturing (CMC) · Supplement 14 · standardAP
1997-05-12Manufacturing (CMC) · Supplement 13 · standardAP
1997-01-29Manufacturing (CMC) · Supplement 12 · standardAP
1996-02-13Labeling · Supplement 9AP
1960-01-19Type 2 New Active Ingredient and Type 4 New Combination · Original · standard — Other Important Information from FDA ↗AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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