APPLICATION
NDA016763
TYPE
NDA
ORIGINAL APPROVAL
1969-01-24
LATEST ACTION
2002-12-13
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
SULFAMYLON · ReferencePrescription
MAFENIDE ACETATE EQ 85MG BASE/GM · CREAM · TOPICAL
Approval history
2002-12-13Manufacturing (CMC) · Supplement 34 · priorityAP
2000-08-31Manufacturing (CMC) · Supplement 33 · priorityAP
1999-01-13Manufacturing (CMC) · Supplement 32 · priorityAP
1998-04-30Manufacturing (CMC) · Supplement 31 · priorityAP
1994-10-14Manufacturing (CMC) · Supplement 30 · priorityAP
1994-09-02Manufacturing (CMC) · Supplement 29 · priorityAP
1990-12-04Manufacturing (CMC) · Supplement 28 · priorityAP
1988-11-01Labeling · Supplement 25AP
1988-03-23Manufacturing (CMC) · Supplement 26 · priorityAP
1984-12-11Labeling · Supplement 23AP
1983-11-03Manufacturing (CMC) · Supplement 21 · priorityAP
1983-08-24Labeling · Supplement 22AP
1983-05-09Manufacturing (CMC) · Supplement 18 · priorityAP
1981-04-28Manufacturing (CMC) · Supplement 20 · priorityAP
1980-07-23Manufacturing (CMC) · Supplement 19 · priorityAP
1977-01-26Manufacturing (CMC) · Supplement 14 · priorityAP
1977-01-11Manufacturing (CMC) · Supplement 16 · priorityAP
1976-07-28Labeling · Supplement 15AP
1969-01-24Type 2 - New Active Ingredient · Original · priorityAP
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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