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FDA ANDA · ANDA208895

CARBIDOPA; LEVODOPA

Sponsor: SANDOZ INC

APPLICATION
ANDA208895
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)

Products

CARBIDOPA; LEVODOPANone (Tentative Approval)
CARBIDOPA 48.75MG, LEVODOPA 195MG · CAPSULE, EXTENDED RELEASE · ORAL
CARBIDOPA; LEVODOPANone (Tentative Approval)
CARBIDOPA 23.75MG, LEVODOPA 95MG · CAPSULE, EXTENDED RELEASE · ORAL
CARBIDOPA; LEVODOPANone (Tentative Approval)
CARBIDOPA 61.25MG, LEVODOPA 245MG · CAPSULE, EXTENDED RELEASE · ORAL
CARBIDOPA; LEVODOPANone (Tentative Approval)
CARBIDOPA 36.25MG, LEVODOPA 145MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2023-03-31UNKNOWN · Original · standard — Letter ↗TA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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.

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