General MedicationsORALStandard

PROTRIPTYLINE HYDROCHLORIDE

Standard Dose

10MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview PROTRIPTYLINE HYDROCHLORIDE is listed in Drugs@FDA under application 202220 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient PROTRIPTYLINE HYDROCHLORIDE Form and strength TABLET;ORAL - 10MG Sponsor EPIC PHARMA LLC Submission history Latest submission status date: 2026-01-07 00:00:00.

Structured Monograph

Clinical summary

Approval overview PROTRIPTYLINE HYDROCHLORIDE is listed in Drugs@FDA under application 202220 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PROTRIPTYLINE HYDROCHLORIDE Form and strength TABLET;ORAL - 10MG Sponsor EPIC PHARMA LLC Submission history Latest submission status date: 2026-01-07 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.