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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE ANDA Tentative Approval DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE | A206304 | COREPHARMA
Products (6) Sort: Name ↑ Applicant Strength Approval
No patent or exclusivity listings for this strength.