General MedicationsINTRAMUSCULARGeneric
NALTREXONE
NALTREXONE
Standard Dose
380MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview NALTREXONE is listed in Drugs@FDA under application 213195 (ANDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient NALTREXONE Form and strength FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 380MG/VIAL Sponsor TEVA PHARMS USA INC Submission history Latest submission status date: 2023-07-06 00:00:00.
Structured Monograph
Clinical summary
Approval overview NALTREXONE is listed in Drugs@FDA under application 213195 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient NALTREXONE Form and strength FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 380MG/VIAL Sponsor TEVA PHARMS USA INC Submission history Latest submission status date: 2023-07-06 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.