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General MedicationsORALStandard

ALPRAZOLAM

ALPRAZOLAM

Standard Dose
0.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription

Key Takeaways

  • Primary indication: Review priority: STANDARD Marketing status: Prescription
  • Approval overview ALPRAZOLAM is listed in Drugs@FDA under application 090871 (ANDA).
  • Review priority: STANDARD Marketing status: Prescription Active ingredient ALPRAZOLAM Form and strength TABLET, EXTENDED RELEASE;ORAL - 0.5MG Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2024-04-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview ALPRAZOLAM is listed in Drugs@FDA under application 090871 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ALPRAZOLAM Form and strength TABLET, EXTENDED RELEASE;ORAL - 0.5MG Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2024-04-11 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.