APPLICATION
ANDA210911
TYPE
ANDA
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)
Products
CARBIDOPA; LEODOPANone (Tentative Approval)
CARBIDOPA 195MG, LEODOPA · CAPSULE, EXTENDED RELEASE
CARBIDOPA; LEODOPANone (Tentative Approval)
CARBIDOPA 61.25MG, LEODOPA · CAPSULE, EXTENDED RELEASE
CARBIDOPA; LEODOPANone (Tentative Approval)
CARBIDOPA 95MG, LEODOPA · CAPSULE, EXTENDED RELEASE
CARBIDOPA; LEODOPANone (Tentative Approval)
CARBIDOPA 145MG, LEODOPA · CAPSULE, EXTENDED RELEASE
CARBIDOPA; LEODOPANone (Tentative Approval)
CARBIDOPA 48.75MG, LEODOPA · CAPSULE, EXTENDED RELEASE
CARBIDOPA; LEODOPANone (Tentative Approval)
CARBIDOPA 245MG, LEODOPA · CAPSULE, EXTENDED RELEASE
CARBIDOPA; LEODOPANone (Tentative Approval)
CARBIDOPA 23.75MG, LEODOPA · CAPSULE, EXTENDED RELEASE
CARBIDOPA; LEODOPANone (Tentative Approval)
CARBIDOPA 36.25MG, LEODOPA · CAPSULE, EXTENDED RELEASE
Approval history
2025-08-08UNKNOWN · Original · unknownTA
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.