APPLICATION
NDA018191
TYPE
NDA
ORIGINAL APPROVAL
1980-10-30
LATEST ACTION
2001-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
AFRINOL · ReferenceDiscontinued
PSEUDOEPHEDRINE SULFATE 120MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2001-07-11Manufacturing (CMC) · Supplement 18 · standardAP
2001-01-24Manufacturing (CMC) · Supplement 16 · standardAP
2000-12-01Manufacturing (CMC) · Supplement 15 · standardAP
2000-10-17Manufacturing (CMC) · Supplement 17 · standardAP
2000-04-18Manufacturing (CMC) · Supplement 14 · standardAP
1998-11-17Manufacturing (CMC) · Supplement 11 · standardAP
1998-10-07Manufacturing (CMC) · Supplement 13 · standardAP
1998-09-22Manufacturing (CMC) · Supplement 12 · standardAP
1996-03-15Labeling · Supplement 8 · standardAP
1989-01-24Manufacturing (CMC) · Supplement 7 · standardAP
1987-09-02Manufacturing (CMC) · Supplement 6 · standardAP
1986-07-08Manufacturing (CMC) · Supplement 5 · standardAP
1984-09-18Manufacturing (CMC) · Supplement 3 · standardAP
1983-01-21Manufacturing (CMC) · Supplement 2 · standardAP
1981-04-10Manufacturing (CMC) · Supplement 1 · standardAP
1980-10-30Type 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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