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FDA NDA · NDA017381

SILVER SULFADIAZINE

Sponsor: KING PHARMS LLC

APPLICATION
NDA017381
TYPE
NDA
ORIGINAL APPROVAL
1973-11-26
LATEST ACTION
2016-08-01
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

SILVADENE · ReferencePrescription
SILVER SULFADIAZINE 1% · CREAM · TOPICAL

Approval history

2016-08-01Labeling · Supplement 53 · standard — Label ↗AP
2015-04-30Manufacturing (CMC) · Supplement 52 · priorityAP
2013-03-06Labeling · Supplement 50 · standard — Letter ↗AP
2012-11-13Manufacturing (CMC) · Supplement 49 · priorityAP
2004-01-29Labeling · Supplement 41 · standard — Letter ↗AP
2001-09-27Manufacturing (CMC) · Supplement 40 · priorityAP
1993-11-04Manufacturing (CMC) · Supplement 39 · priorityAP
1992-12-07Manufacturing (CMC) · Supplement 38 · priorityAP
1992-10-05Labeling · Supplement 34AP
1992-02-27Manufacturing (CMC) · Supplement 37 · priorityAP
1991-05-13Manufacturing (CMC) · Supplement 36 · priorityAP
1991-01-29Manufacturing (CMC) · Supplement 35 · priorityAP
1988-11-14Labeling · Supplement 32AP
1987-10-29Manufacturing (CMC) · Supplement 31 · priorityAP
1986-11-28Labeling · Supplement 30AP
1985-11-15Manufacturing (CMC) · Supplement 29 · priorityAP
1984-06-12Manufacturing (CMC) · Supplement 28 · priorityAP
1984-05-31Manufacturing (CMC) · Supplement 27 · priorityAP
1982-12-06Manufacturing (CMC) · Supplement 24 · priorityAP
1982-12-06Manufacturing (CMC) · Supplement 25 · priorityAP
1982-09-15Manufacturing (CMC) · Supplement 21 · priorityAP
1982-09-10Manufacturing (CMC) · Supplement 23 · priorityAP
1982-04-19Manufacturing (CMC) · Supplement 22 · priorityAP
1982-04-19Manufacturing (CMC) · Supplement 20 · priorityAP
1981-08-28Manufacturing (CMC) · Supplement 18 · priorityAP
1981-03-04Manufacturing (CMC) · Supplement 19 · priorityAP
1980-06-26Manufacturing (CMC) · Supplement 17 · priorityAP
1979-11-26Manufacturing (CMC) · Supplement 16 · priorityAP
1979-07-06Manufacturing (CMC) · Supplement 14 · priorityAP
1979-06-14Labeling · Supplement 15AP
1979-04-17Manufacturing (CMC) · Supplement 12 · priorityAP
1978-09-28Manufacturing (CMC) · Supplement 10 · priorityAP
1978-07-24Labeling · Supplement 11AP
1978-01-31Manufacturing (CMC) · Supplement 9 · priorityAP
1977-05-24Manufacturing (CMC) · Supplement 6 · priorityAP
1977-05-02Manufacturing (CMC) · Supplement 7 · priorityAP
1977-04-06Manufacturing (CMC) · Supplement 8 · priorityAP
1977-01-24Manufacturing (CMC) · Supplement 4 · priorityAP
1975-07-17Manufacturing (CMC) · Supplement 2 · priorityAP
1974-11-11Labeling · Supplement 1AP
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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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