General MedicationsORALStandard

DEXTROAMPHETAMINE SULFATE

Standard Dose

2.5MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview DEXTROAMPHETAMINE SULFATE is listed in Drugs@FDA under application 212160 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DEXTROAMPHETAMINE SULFATE Form and strength TABLET;ORAL - 2.5MG Sponsor WINDER LABS LLC Submission history Latest submission status date: 2023-12-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview DEXTROAMPHETAMINE SULFATE is listed in Drugs@FDA under application 212160 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEXTROAMPHETAMINE SULFATE Form and strength TABLET;ORAL - 2.5MG Sponsor WINDER LABS LLC Submission history Latest submission status date: 2023-12-26 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.