APPLICATION
NDA018506
TYPE
NDA
ORIGINAL APPROVAL
1982-03-23
LATEST ACTION
2002-12-12
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
TRINALINDiscontinued
AZATADINE MALEATE 1MG, PSEUDOEPHEDRINE SULFATE 120MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2000-08-04Manufacturing (CMC) · Supplement 21 · standardAP
2000-04-25Manufacturing (CMC) · Supplement 19 · standardAP
1998-05-18Manufacturing (CMC) · Supplement 16 · standardAP
1992-07-01Manufacturing (CMC) · Supplement 15 · standardAP
1992-04-20Manufacturing (CMC) · Supplement 14 · standardAP
1989-01-24Manufacturing (CMC) · Supplement 12 · standardAP
1989-01-24Manufacturing (CMC) · Supplement 11 · standardAP
1988-04-06Manufacturing (CMC) · Supplement 10 · standardAP
1987-05-01Manufacturing (CMC) · Supplement 9 · standardAP
1986-07-08Manufacturing (CMC) · Supplement 8 · standardAP
1985-07-02Manufacturing (CMC) · Supplement 7 · standardAP
1985-03-04Manufacturing (CMC) · Supplement 4 · standardAP
1985-02-06Manufacturing (CMC) · Supplement 1 · standardAP
1984-09-18Manufacturing (CMC) · Supplement 5 · standardAP
1984-08-31Manufacturing (CMC) · Supplement 3 · standardAP
1984-02-24Manufacturing (CMC) · Supplement 2 · standardAP
1982-03-23Type 4 - New Combination · 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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