APPLICATION
ANDA074260
TYPE
ANDA
ORIGINAL APPROVAL
1993-09-03
LATEST ACTION
2021-02-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 25MG, LEVODOPA 250MG · TABLET · ORAL
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 10MG, LEVODOPA 100MG · TABLET · ORAL
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 25MG, LEVODOPA 100MG · TABLET · ORAL
Approval history
2021-02-04Labeling · Supplement 55 · standardAP
2016-02-15Labeling · Supplement 44 · standardAP
2014-11-04Manufacturing (CMC) · Supplement 33AP
2009-10-29Labeling · Supplement 32AP
2007-06-19Manufacturing (CMC) · Supplement 25AP
2002-05-15Manufacturing (CMC) · Supplement 10AP
2001-11-16Labeling · Supplement 9AP
2001-11-02Manufacturing (CMC) · Supplement 8AP
2000-09-11Manufacturing (CMC) · Supplement 7AP
2000-03-20Manufacturing (CMC) · Supplement 6AP
2000-03-20Manufacturing (CMC) · Supplement 5AP
1998-04-15Manufacturing (CMC) · Supplement 4AP
1996-01-18Manufacturing (CMC) · Supplement 3AP
1995-11-21Manufacturing (CMC) · Supplement 1AP
1995-11-21Manufacturing (CMC) · Supplement 2AP
1993-09-03OriginalAP
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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