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FDA ANDA · ANDA212582

AMPHETAMINE SULFATE

amphetamine sulfate tablets

Sponsor: SANALUZ

APPLICATION
ANDA212582
TYPE
ANDA
ORIGINAL APPROVAL
2020-02-04
LATEST ACTION
2023-10-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2023-10-16Labeling · Supplement 4 · standardAP
2023-10-16Labeling · Supplement 3 · standardAP
2022-02-25Labeling · Supplement 1 · standardAP
2020-02-04UNKNOWN · 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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