APPLICATION
NDA011340
TYPE
NDA
ORIGINAL APPROVAL
1958-06-25
LATEST ACTION
2002-04-17
ROUTE
OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
CERUMENEXDiscontinued
TROLAMINE POLYPEPTIDE OLEATE CONDENSATE 10% · SOLUTION/DROPS · OTIC
Approval history
2000-11-09Manufacturing (CMC) · Supplement 13 · standardAP
2000-11-09Manufacturing (CMC) · Supplement 11 · standardAP
2000-11-09Manufacturing (CMC) · Supplement 14 · standardAP
2000-11-09Manufacturing (CMC) · Supplement 12 · standardAP
2000-11-09Manufacturing (CMC) · Supplement 10 · standardAP
2000-11-09Manufacturing (CMC) · Supplement 15 · standardAP
2000-02-11Manufacturing (CMC) · Supplement 9 · standardAP
1991-08-21Labeling · Supplement 8 · standardAP
1988-12-02Labeling · Supplement 7 · standardAP
1981-06-04Manufacturing (CMC) · Supplement 6 · standardAP
1977-10-07Manufacturing (CMC) · Supplement 5 · standardAP
1958-06-25Type 1 - New Molecular Entity · 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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