← FDA DRUG APPROVALS

FDA ANDA · ANDA077488

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Sponsor: TEVA

APPLICATION
ANDA077488
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-29
LATEST ACTION
2015-08-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEDiscontinued
AMPHETAMINE ASPARTATE 5MG, AMPHETAMINE SULFATE 5MG, DEXTROAMPHETAMINE SACCHARATE 5MG, DEXTROAMPHETAMINE SULFATE 5MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEDiscontinued
AMPHETAMINE ASPARTATE 2.5MG, AMPHETAMINE SULFATE 2.5MG, DEXTROAMPHETAMINE SACCHARATE 2.5MG, DEXTROAMPHETAMINE SULFATE 2.5MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEDiscontinued
AMPHETAMINE ASPARTATE 6.25MG, AMPHETAMINE SULFATE 6.25MG, DEXTROAMPHETAMINE SACCHARATE 6.25MG, DEXTROAMPHETAMINE SULFATE 6.25MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEDiscontinued
AMPHETAMINE ASPARTATE 3.75MG, AMPHETAMINE SULFATE 3.75MG, DEXTROAMPHETAMINE SACCHARATE 3.75MG, DEXTROAMPHETAMINE SULFATE 3.75MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEDiscontinued
AMPHETAMINE ASPARTATE 1.25MG, AMPHETAMINE SULFATE 1.25MG, DEXTROAMPHETAMINE SACCHARATE 1.25MG, DEXTROAMPHETAMINE SULFATE 1.25MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEDiscontinued
AMPHETAMINE ASPARTATE 7.5MG, AMPHETAMINE SULFATE 7.5MG, DEXTROAMPHETAMINE SACCHARATE 7.5MG, DEXTROAMPHETAMINE SULFATE 7.5MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2015-08-25Labeling · Supplement 3 · standardAP
2015-08-25Labeling · Supplement 1 · standardAP
2015-08-25Labeling · Supplement 2 · standardAP
2013-04-29OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →