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General MedicationsORALStandard

DEXEDRINE SPANSULE

DEXTROAMPHETAMINE SULFATE

Standard Dose
10MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DEXEDRINE SPANSULE is listed in Drugs@FDA under application 017078 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DEXTROAMPHETAMINE SULFATE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 10MG Sponsor IMPAX LABS INC Submission history Latest submission status date: 2025-09-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview DEXEDRINE SPANSULE is listed in Drugs@FDA under application 017078 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEXTROAMPHETAMINE SULFATE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 10MG Sponsor IMPAX LABS INC Submission history Latest submission status date: 2025-09-23 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.