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FDA ANDA · ANDA204330

DEXTROAMPHETAMINE SULFATE

Sponsor: NOVEL LABS INC

APPLICATION
ANDA204330
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-16
LATEST ACTION
2023-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 10MG · TABLET · ORAL
DEXTROAMPHETAMINE SULFATEPrescription
DEXTROAMPHETAMINE SULFATE 5MG · TABLET · ORAL

Approval history

2023-10-13Labeling · Supplement 3 · standardAP
2022-02-25Labeling · Supplement 2 · standardAP
2022-02-15Labeling · Supplement 1 · standardAP
2016-03-16UNKNOWN · OriginalAP
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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