General MedicationsORALGeneric
NIMODIPINE
NIMODIPINE
Standard Dose
60MG/10ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview NIMODIPINE is listed in Drugs@FDA under application 213409 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient NIMODIPINE Form and strength SOLUTION;ORAL - 60MG/10ML Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2025-01-22 00:00:00.
Structured Monograph
Clinical summary
Approval overview NIMODIPINE is listed in Drugs@FDA under application 213409 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient NIMODIPINE Form and strength SOLUTION;ORAL - 60MG/10ML Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2025-01-22 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.