General MedicationsSUBCUTANEOUSGeneric

METHYLNALTREXONE BROMIDE

Standard Dose

8MG/0.4ML (8MG/0.4ML)

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 208112 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient METHYLNALTREXONE BROMIDE Form and strength SOLUTION;SUBCUTANEOUS - 8MG/0.4ML (8MG/0.4ML) Sponsor ACTAVIS LLC Submission history Latest submission status date: 2024-08-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview METHYLNALTREXONE BROMIDE is listed in Drugs@FDA under application 208112 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient METHYLNALTREXONE BROMIDE Form and strength SOLUTION;SUBCUTANEOUS - 8MG/0.4ML (8MG/0.4ML) Sponsor ACTAVIS LLC Submission history Latest submission status date: 2024-08-26 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.