APPLICATION
NDA007936
TYPE
NDA
ORIGINAL APPROVAL
1951-05-17
LATEST ACTION
1994-06-24
ROUTE
TOPICAL
DOSAGE FORM
LOTION/SHAMPOO
MARKETING STATUS
Discontinued
Products
SELSUN · ReferenceDiscontinued
SELENIUM SULFIDE 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LOTION/SHAMPOO · TOPICAL
Approval history
1994-06-24Manufacturing (CMC) · Supplement 20 · standardAP
1993-01-19Manufacturing (CMC) · Supplement 19 · standardAP
1988-05-17Manufacturing (CMC) · Supplement 17 · standardAP
1983-09-23Labeling · Supplement 16AP
1983-01-26Labeling · Supplement 14AP
1982-09-15Manufacturing (CMC) · Supplement 15 · standardAP
1981-01-09Manufacturing (CMC) · Supplement 13 · standardAP
1979-01-16Manufacturing (CMC) · Supplement 11 · standardAP
1979-01-15Manufacturing (CMC) · Supplement 10 · standardAP
1977-09-19Manufacturing (CMC) · Supplement 9 · standardAP
1977-03-07Manufacturing (CMC) · Supplement 8 · standardAP
1977-03-07Manufacturing (CMC) · Supplement 7 · standardAP
1976-11-29Manufacturing (CMC) · Supplement 6 · standardAP
1976-07-01Manufacturing (CMC) · Supplement 5 · standardAP
1951-05-17Type 3 - New Dosage Form · 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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