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General MedicationsORALStandard

NUCYNTA ER

TAPENTADOL HYDROCHLORIDE

Standard Dose
EQ 50MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NUCYNTA ER is listed in Drugs@FDA under application 200533 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient TAPENTADOL HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE Sponsor COLLEGIUM PHARM INC Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview NUCYNTA ER is listed in Drugs@FDA under application 200533 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TAPENTADOL HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE Sponsor COLLEGIUM PHARM INC Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.