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FDA NDA · NDA014860
ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE
Sponsor: SANOFI AVENTIS US
APPLICATION
NDA014860
TYPE
NDA
ORIGINAL APPROVAL
1968-12-09
LATEST ACTION
1990-05-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATEDiscontinued
CHLOROQUINE PHOSPHATE EQ 300MG BASE, PRIMAQUINE PHOSPHATE EQ 45MG BASE · TABLET · ORAL
Approval history
1990-05-29Manufacturing (CMC) · Supplement 15 · priorityAP
1987-03-03Labeling · Supplement 14 · priorityAP
1986-12-04Labeling · Supplement 12 · priorityAP
1984-01-26Manufacturing (CMC) · Supplement 13 · priorityAP
1981-05-15Manufacturing (CMC) · Supplement 11 · priorityAP
1981-05-15Manufacturing (CMC) · Supplement 10 · priorityAP
1976-09-09Manufacturing (CMC) · Supplement 9 · priorityAP
1968-12-09Type 4 - New Combination · Original · priorityAP
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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