APPLICATION
ANDA213409
TYPE
ANDA
ORIGINAL APPROVAL
2025-01-22
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
None (Tentative Approval), Prescription
Products
NIMODIPINENone (Tentative Approval)
NIMODIPINE 60MG/10ML · SOLUTION · ORAL
NIMODIPINEPrescription
NIMODIPINE 6MG/ML · SOLUTION · ORAL
Approval history
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.