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General MedicationsORALStandard

EXTENDED PHENYTOIN SODIUM

PHENYTOIN SODIUM

Standard Dose
100MG EXTENDED
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 EXTENDED PHENYTOIN SODIUM is listed in Drugs@FDA under application 219773 (ANDA).
  • Review priority: STANDARD Marketing status: Prescription Active ingredient PHENYTOIN SODIUM Form and strength CAPSULE;ORAL - 100MG EXTENDED Sponsor MANKIND PHARMA Submission history Latest submission status date: 2026-01-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview EXTENDED PHENYTOIN SODIUM is listed in Drugs@FDA under application 219773 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PHENYTOIN SODIUM Form and strength CAPSULE;ORAL - 100MG EXTENDED Sponsor MANKIND PHARMA Submission history Latest submission status date: 2026-01-02 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.