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General MedicationsORALStandard

CONTRAVE

BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE

Standard Dose
90MG;8MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: 901 REQUIRED Marketing status: Prescription
Summary

Approval overview CONTRAVE is listed in Drugs@FDA under application 200063 (NDA).

Review priority: 901 REQUIRED Marketing status: Prescription Active ingredient BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG Sponsor NALPROPION Submission history Latest submission status date: 2025-11-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview CONTRAVE is listed in Drugs@FDA under application 200063 (NDA). Review priority: 901 REQUIRED Marketing status: Prescription Active ingredient BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG Sponsor NALPROPION Submission history Latest submission status date: 2025-11-05 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: 901 REQUIRED

Interaction Notes

  • No interaction notes stored yet.