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General MedicationsINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSStandard

NALMEFENE HYDROCHLORIDE

NALMEFENE HYDROCHLORIDE

Standard Dose
EQ 2MG BASE/2ML (EQ 1MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NALMEFENE HYDROCHLORIDE is listed in Drugs@FDA under application 216007 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NALMEFENE HYDROCHLORIDE Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - EQ 2MG BASE/2ML (EQ 1MG BASE/ML) Sponsor CHENGDU SHUODE Submission history Latest submission status date: 2023-11-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview NALMEFENE HYDROCHLORIDE is listed in Drugs@FDA under application 216007 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NALMEFENE HYDROCHLORIDE Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - EQ 2MG BASE/2ML (EQ 1MG BASE/ML) Sponsor CHENGDU SHUODE Submission history Latest submission status date: 2023-11-15 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.