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General MedicationsORALStandard

PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

Standard Dose
EQ 15MG BASE;92MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE is listed in Drugs@FDA under application 208175 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient PHENTERMINE HYDROCHLORIDE; TOPIRAMATE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - EQ 15MG BASE;92MG Sponsor DR REDDYS LABS SA Submission history Latest submission status date: 2025-06-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE is listed in Drugs@FDA under application 208175 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PHENTERMINE HYDROCHLORIDE; TOPIRAMATE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - EQ 15MG BASE;92MG Sponsor DR REDDYS LABS SA Submission history Latest submission status date: 2025-06-12 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.