APPLICATION
NDA018578
TYPE
NDA
ORIGINAL APPROVAL
1982-02-25
LATEST ACTION
2014-04-21
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued, Prescription
Products
SSD AFDiscontinued
SILVER SULFADIAZINE 1% · CREAM · TOPICAL
SSD · ReferencePrescription
SILVER SULFADIAZINE 1% · CREAM · TOPICAL
Approval history
2014-04-21Manufacturing (CMC) · Supplement 16 · standardAP
2000-05-24Manufacturing (CMC) · Supplement 13 · standardAP
1999-01-12Manufacturing (CMC) · Supplement 12 · standardAP
1995-01-11Manufacturing (CMC) · Supplement 11 · standardAP
1990-08-03Manufacturing (CMC) · Supplement 9 · standardAP
1990-07-11Manufacturing (CMC) · Supplement 8 · standardAP
1990-07-11Labeling · Supplement 6AP
1989-03-15Manufacturing (CMC) · Supplement 7 · standardAP
1985-12-10Labeling · Supplement 5AP
1985-01-29Manufacturing (CMC) · Supplement 1 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 4 · standardAP
1983-08-19Labeling · Supplement 3AP
1983-05-12Manufacturing (CMC) · Supplement 2 · standardAP
1982-02-25Type 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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