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General MedicationsORALGeneric

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

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

Standard Dose
30MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE is listed in Drugs@FDA under application 206304 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 30MG Sponsor COREPHARMA Submission history Latest submission status date: 2016-04-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE is listed in Drugs@FDA under application 206304 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 30MG Sponsor COREPHARMA Submission history Latest submission status date: 2016-04-15 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.