← FDA DRUG APPROVALS

FDA ANDA · ANDA206304

DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE

Sponsor: COREPHARMA

APPLICATION
ANDA206304
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)

Products

DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATENone (Tentative Approval)
DEXTROAMPHETAMINE SACCHARATE 15MG, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATENone (Tentative Approval)
DEXTROAMPHETAMINE SACCHARATE 5MG, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATENone (Tentative Approval)
DEXTROAMPHETAMINE SACCHARATE 30MG, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATENone (Tentative Approval)
DEXTROAMPHETAMINE SACCHARATE 20MG, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATENone (Tentative Approval)
DEXTROAMPHETAMINE SACCHARATE 10MG, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE · CAPSULE, EXTENDED RELEASE · ORAL
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATENone (Tentative Approval)
DEXTROAMPHETAMINE SACCHARATE 25MG, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2016-04-15UNKNOWN · Original · standardTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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