APPLICATION
ANDA075091
TYPE
ANDA
ORIGINAL APPROVAL
1999-09-30
LATEST ACTION
2015-05-27
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 25MG, LEVODOPA 100MG · TABLET, EXTENDED RELEASE · ORAL
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 50MG, LEVODOPA 200MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2015-05-27Labeling · Supplement 26 · standardAP
2012-05-14Labeling · Supplement 24AP
2002-10-01Manufacturing (CMC) · Supplement 8AP
2002-06-12Manufacturing (CMC) · Supplement 7AP
2001-11-07Labeling · Supplement 6AP
2000-08-11Manufacturing (CMC) · Supplement 4AP
2000-08-11Manufacturing (CMC) · Supplement 5AP
2000-04-21Manufacturing (CMC) · Supplement 1AP
2000-04-21Labeling · Supplement 2AP
2000-02-04Labeling · Supplement 3AP
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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