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General MedicationsORALGeneric

NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE

NALTREXONE HYDROCHLORIDE;BUPROPION HYDROCHLORIDE

Standard Dose
8MG/90MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE is listed in Drugs@FDA under application 208043 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient NALTREXONE HYDROCHLORIDE;BUPROPION HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE; ORAL - 8MG/90MG Sponsor ACTAVIS LABS FL INC Submission history Latest submission status date: 2022-11-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE is listed in Drugs@FDA under application 208043 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient NALTREXONE HYDROCHLORIDE;BUPROPION HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE; ORAL - 8MG/90MG Sponsor ACTAVIS LABS FL INC Submission history Latest submission status date: 2022-11-29 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.