← FDA DRUG APPROVALS

FDA ANDA · ANDA211546

MIXED SALTS OF A SINGLE-ENTITY AMPHETAMINE PRODUCT

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate

Sponsor: SPECGX LLC

APPLICATION
ANDA211546
TYPE
ANDA
ORIGINAL APPROVAL
2023-08-31
LATEST ACTION
2023-08-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription
AMPHETAMINE ASPARTATE 12.5MG, AMPHETAMINE SULFATE 12.5MG, DEXTROAMPHETAMINE SACCHARATE 12.5MG, DEXTROAMPHETAMINE SULFATE 12.5MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription
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 SULFATEPrescription
AMPHETAMINE ASPARTATE 9.375MG, AMPHETAMINE SULFATE 9.375MG, DEXTROAMPHETAMINE SACCHARATE 9.375MG, DEXTROAMPHETAMINE SULFATE 9.375MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEPrescription
AMPHETAMINE ASPARTATE 3.125MG, AMPHETAMINE SULFATE 3.125MG, DEXTROAMPHETAMINE SACCHARATE 3.125MG, DEXTROAMPHETAMINE SULFATE 3.125MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2023-08-31UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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