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FDA NDA · NDA017830

CARBIDOPA

carbidopa tablets

Sponsor: ATON

APPLICATION
NDA017830
TYPE
NDA
ORIGINAL APPROVAL
1977-04-25
LATEST ACTION
2014-02-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LODOSYN · ReferencePrescription
CARBIDOPA 25MG · TABLET · ORAL

Approval history

2014-02-21Labeling · Supplement 18 · standard — Letter ↗AP
2014-02-21Labeling · Supplement 16 · standard — Label ↗AP
2014-02-21Labeling · Supplement 30 · standard — Letter ↗AP
2014-02-21Labeling · Supplement 14 — Letter ↗AP
2014-02-21Labeling · Supplement 19 · standard — Label ↗AP
2014-02-21Labeling · Supplement 17 · standard — Letter ↗AP
2002-12-18Manufacturing (CMC) · Supplement 24 · priorityAP
2002-09-05Manufacturing (CMC) · Supplement 25 · priorityAP
2002-04-29Manufacturing (CMC) · Supplement 23 · priorityAP
2001-10-11Manufacturing (CMC) · Supplement 22 · priorityAP
2001-03-16Manufacturing (CMC) · Supplement 21 · priorityAP
1995-01-06Manufacturing (CMC) · Supplement 15 · priorityAP
1986-01-27Labeling · Supplement 12AP
1986-01-27Labeling · Supplement 7AP
1986-01-27Labeling · Supplement 8AP
1986-01-08Labeling · Supplement 13AP
1985-07-30Labeling · Supplement 11AP
1985-03-08Manufacturing (CMC) · Supplement 10 · priorityAP
1983-11-28Manufacturing (CMC) · Supplement 9 · priorityAP
1981-09-14Manufacturing (CMC) · Supplement 5 · priorityAP
1980-07-21Labeling · Supplement 4AP
1980-03-28Labeling · Supplement 3AP
1977-09-28Labeling · Supplement 1AP
1977-04-25Type 3 - New Dosage Form · Original · priorityAP
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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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