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General MedicationsSUBCUTANEOUSGeneric

METHYLNALTREXONE BROMIDE

METHYLNALTREXONE BROMIDE

Standard Dose
12MG/0.6ML (12MG/0.6ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview METHYLNALTREXONE BROMIDE is listed in Drugs@FDA under application 208592 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient METHYLNALTREXONE BROMIDE Form and strength SOLUTION;SUBCUTANEOUS - 12MG/0.6ML (12MG/0.6ML) Sponsor MYLAN LABS LTD Submission history Latest submission status date: 2025-05-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview METHYLNALTREXONE BROMIDE is listed in Drugs@FDA under application 208592 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient METHYLNALTREXONE BROMIDE Form and strength SOLUTION;SUBCUTANEOUS - 12MG/0.6ML (12MG/0.6ML) Sponsor MYLAN LABS LTD Submission history Latest submission status date: 2025-05-28 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.