← FDA DRUG APPROVALS
FDA ANDA · ANDA219421
BEMPEDOIC ACID AND EZETIMIBE
Sponsor: ALKEM LABORATORIES LIMITED
APPLICATION
ANDA219421
TYPE
ANDA
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
BEMPEDOIC ACID AND EZETIMIBENone (Tentative Approval)
BEMPEDOIC ACID, EZETIMIBE 180MG · TABLET
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.