APPLICATION
NDA017823
TYPE
NDA
ORIGINAL APPROVAL
1977-05-04
LATEST ACTION
2020-03-18
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
HALOG · ReferencePrescription
HALCINONIDE 0.1% · SOLUTION · TOPICAL
Approval history
1996-10-08Manufacturing (CMC) · Supplement 22 · standardAP
1992-06-23Manufacturing (CMC) · Supplement 21 · standardAP
1989-06-27Manufacturing (CMC) · Supplement 20 · standardAP
1988-03-02Manufacturing (CMC) · Supplement 19 · standardAP
1985-07-30Manufacturing (CMC) · Supplement 18 · standardAP
1985-01-22Manufacturing (CMC) · Supplement 17 · standardAP
1984-08-30Manufacturing (CMC) · Supplement 16 · standardAP
1984-05-31Manufacturing (CMC) · Supplement 15 · standardAP
1983-01-21Labeling · Supplement 14AP
1981-12-30Manufacturing (CMC) · Supplement 13 · standardAP
1980-08-12Manufacturing (CMC) · Supplement 11 · standardAP
1980-06-20Manufacturing (CMC) · Supplement 10 · standardAP
1980-04-18Labeling · Supplement 5AP
1980-02-13Manufacturing (CMC) · Supplement 9 · standardAP
1980-01-29Manufacturing (CMC) · Supplement 8 · standardAP
1979-04-18Manufacturing (CMC) · Supplement 7 · standardAP
1979-01-10Manufacturing (CMC) · Supplement 6 · standardAP
1978-05-12Manufacturing (CMC) · Supplement 4 · standardAP
1978-01-09Manufacturing (CMC) · Supplement 3 · standardAP
1977-08-24Manufacturing (CMC) · Supplement 1 · standardAP
1977-05-04Type 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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