APPLICATION
NDA017556
TYPE
NDA
ORIGINAL APPROVAL
1974-11-27
LATEST ACTION
2014-04-02
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
HALOG · ReferencePrescription
HALCINONIDE 0.1% · CREAM · TOPICAL
Approval history
2014-04-02Manufacturing (CMC) · Supplement 41 · standardAP
1990-06-29Manufacturing (CMC) · Supplement 33 · standardAP
1989-06-27Manufacturing (CMC) · Supplement 32 · standardAP
1989-03-23Manufacturing (CMC) · Supplement 31 · standardAP
1987-11-03Manufacturing (CMC) · Supplement 30 · standardAP
1986-05-27Manufacturing (CMC) · Supplement 29 · standardAP
1986-04-22Manufacturing (CMC) · Supplement 28 · standardAP
1985-07-30Manufacturing (CMC) · Supplement 27 · standardAP
1985-01-28Manufacturing (CMC) · Supplement 26 · standardAP
1984-05-24Manufacturing (CMC) · Supplement 25 · standardAP
1982-11-26Labeling · Supplement 23AP
1982-03-18Manufacturing (CMC) · Supplement 24 · standardAP
1980-05-20Manufacturing (CMC) · Supplement 22 · standardAP
1980-03-24Manufacturing (CMC) · Supplement 21 · standardAP
1980-02-13Labeling · Supplement 19AP
1979-02-02Manufacturing (CMC) · Supplement 18 · standardAP
1979-01-10Manufacturing (CMC) · Supplement 17 · standardAP
1978-06-07Manufacturing (CMC) · Supplement 15 · standardAP
1978-06-07Labeling · Supplement 16AP
1978-04-19Manufacturing (CMC) · Supplement 13 · standardAP
1978-01-09Manufacturing (CMC) · Supplement 12 · standardAP
1977-08-24Manufacturing (CMC) · Supplement 11 · standardAP
1977-03-08Labeling · Supplement 8AP
1976-02-09Manufacturing (CMC) · Supplement 7 · standardAP
1975-05-07Manufacturing (CMC) · Supplement 3 · standardAP
1975-04-04Labeling · Supplement 4AP
1974-11-27Type 1 - New Molecular Entity · 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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