APPLICATION
NDA018810
TYPE
NDA
ORIGINAL APPROVAL
1985-12-23
LATEST ACTION
2016-08-11
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
THERMAZENEPrescription
SILVER SULFADIAZINE 1% · CREAM · TOPICAL
Approval history
2016-08-11Manufacturing (CMC) · Supplement 20AP
2012-11-27Manufacturing (CMC) · Supplement 19 · standardAP
2001-09-27Manufacturing (CMC) · Supplement 12 · standardAP
1997-08-07Manufacturing (CMC) · Supplement 11 · standardAP
1990-05-10Labeling · Supplement 8AP
1989-10-24Manufacturing (CMC) · Supplement 7 · standardAP
1989-05-30Manufacturing (CMC) · Supplement 6 · standardAP
1989-04-12Manufacturing (CMC) · Supplement 5 · standardAP
1987-01-12Manufacturing (CMC) · Supplement 4 · standardAP
1986-11-17Manufacturing (CMC) · Supplement 2 · standardAP
1986-11-17Manufacturing (CMC) · Supplement 1 · standardAP
1986-11-04Manufacturing (CMC) · Supplement 3 · standardAP
1985-12-23Type 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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