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General MedicationsORALStandard

PAROXETINE HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE

Standard Dose
EQ 37.5MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: UNKNOWN Marketing status: Prescription
Summary

Approval overview PAROXETINE HYDROCHLORIDE is listed in Drugs@FDA under application 217280 (ANDA).

Review priority: UNKNOWN Marketing status: Prescription Active ingredient PAROXETINE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 37.5MG BASE Sponsor ALEMBIC Submission history Latest submission status date: 2026-03-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview PAROXETINE HYDROCHLORIDE is listed in Drugs@FDA under application 217280 (ANDA). Review priority: UNKNOWN Marketing status: Prescription Active ingredient PAROXETINE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 37.5MG BASE Sponsor ALEMBIC Submission history Latest submission status date: 2026-03-26 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: UNKNOWN

Interaction Notes

  • No interaction notes stored yet.