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General MedicationsORALGeneric

AMPHETAMINE

AMPHETAMINE

Standard Dose
6.3MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview AMPHETAMINE is listed in Drugs@FDA under application 219800 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient AMPHETAMINE Form and strength TABLET, ORALLY DISINTEGRATING;ORAL - 6.3MG Sponsor GRANULES PHARMACEUTICALS INC Submission history Latest submission status date: 2025-12-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMPHETAMINE is listed in Drugs@FDA under application 219800 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient AMPHETAMINE Form and strength TABLET, ORALLY DISINTEGRATING;ORAL - 6.3MG Sponsor GRANULES PHARMACEUTICALS INC Submission history Latest submission status date: 2025-12-19 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.