APPLICATION
ANDA219800
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
None (Tentative Approval)
Products
AMPHETAMINENone (Tentative Approval)
AMPHETAMINE 6.3MG · TABLET, ORALLY DISINTEGRATING · ORAL
AMPHETAMINENone (Tentative Approval)
AMPHETAMINE 15.7MG · TABLET, ORALLY DISINTEGRATING · ORAL
AMPHETAMINENone (Tentative Approval)
AMPHETAMINE 9.4MG · TABLET, ORALLY DISINTEGRATING · ORAL
AMPHETAMINENone (Tentative Approval)
AMPHETAMINE 3.1MG · TABLET, ORALLY DISINTEGRATING · ORAL
AMPHETAMINENone (Tentative Approval)
AMPHETAMINE 18.8MG · TABLET, ORALLY DISINTEGRATING · ORAL
AMPHETAMINENone (Tentative Approval)
AMPHETAMINE 12.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2025-12-19UNKNOWN · Original · standardTA
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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