APPLICATION
NDA018050
TYPE
NDA
ORIGINAL APPROVAL
1984-01-04
LATEST ACTION
1988-04-15
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
CORSYMDiscontinued
CHLORPHENIRAMINE POLISTIREX EQ 4MG MALEATE/5ML, PHENYLPROPANOLAMINE POLISTIREX EQ 37.5MG HCL/5ML · SUSPENSION, EXTENDED RELEASE · ORAL
Approval history
1988-04-15Manufacturing (CMC) · Supplement 9 · standardAP
1987-05-08Manufacturing (CMC) · Supplement 8 · standardAP
1987-02-19Manufacturing (CMC) · Supplement 6 · standardAP
1986-07-28Manufacturing (CMC) · Supplement 4 · standardAP
1985-11-22Manufacturing (CMC) · Supplement 3 · standardAP
1985-07-24Manufacturing (CMC) · Supplement 2 · standardAP
1984-10-16Manufacturing (CMC) · Supplement 1 · standardAP
1984-01-04Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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