General MedicationsSUBCUTANEOUSGeneric

METHYLNALTREXONE BROMIDE

Standard Dose

12MG/0.6ML

Max Dose

Refer to approved labeling

Primary Use

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

Summary

Approval overview METHYLNALTREXONE BROMIDE is listed in Drugs@FDA under application 208038 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient METHYLNALTREXONE BROMIDE Form and strength SOLUTION;SUBCUTANEOUS - 12MG/0.6ML Sponsor US GENERICS, STERILES Submission history Latest submission status date: 2021-08-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview METHYLNALTREXONE BROMIDE is listed in Drugs@FDA under application 208038 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient METHYLNALTREXONE BROMIDE Form and strength SOLUTION;SUBCUTANEOUS - 12MG/0.6ML Sponsor US GENERICS, STERILES Submission history Latest submission status date: 2021-08-12 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

No interaction notes stored yet.