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General MedicationsORALStandard

AMITRIPTYLINE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE

Standard Dose
100MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview AMITRIPTYLINE HYDROCHLORIDE is listed in Drugs@FDA under application 218389 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMITRIPTYLINE HYDROCHLORIDE Form and strength TABLET;ORAL - 100MG Sponsor UNIQUE PHARM Submission history Latest submission status date: 2026-01-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMITRIPTYLINE HYDROCHLORIDE is listed in Drugs@FDA under application 218389 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMITRIPTYLINE HYDROCHLORIDE Form and strength TABLET;ORAL - 100MG Sponsor UNIQUE PHARM Submission history Latest submission status date: 2026-01-09 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.