General MedicationsORALStandard

AMPHETAMINE

Standard Dose

EQ 9.4MG BASE

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview AMPHETAMINE is listed in Drugs@FDA under application 209253 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMPHETAMINE Form and strength TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 9.4MG BASE Sponsor ACTAVIS LABS FL INC Submission history Latest submission status date: 2025-08-08 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMPHETAMINE is listed in Drugs@FDA under application 209253 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMPHETAMINE Form and strength TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 9.4MG BASE Sponsor ACTAVIS LABS FL INC Submission history Latest submission status date: 2025-08-08 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.