APPLICATION
NDA016322
TYPE
NDA
ORIGINAL APPROVAL
1967-09-02
LATEST ACTION
1991-11-08
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
VALISONEDiscontinued
BETAMETHASONE VALERATE EQ 0.1% BASE · CREAM · TOPICAL
VALISONEDiscontinued
BETAMETHASONE VALERATE EQ 0.01% BASE · CREAM · TOPICAL
Approval history
1991-11-08Manufacturing (CMC) · Supplement 23 · standardAP
1987-10-29Manufacturing (CMC) · Supplement 22 · standardAP
1986-09-12Manufacturing (CMC) · Supplement 20 · standardAP
1986-05-20Manufacturing (CMC) · Supplement 19 · standardAP
1986-04-23Manufacturing (CMC) · Supplement 17 · standardAP
1984-05-31Manufacturing (CMC) · Supplement 16 · standardAP
1983-10-05Labeling · Supplement 15 · standardAP
1982-12-13Labeling · Supplement 12 · standardAP
1982-04-16Manufacturing (CMC) · Supplement 14 · standardAP
1981-09-15Manufacturing (CMC) · Supplement 13 · standardAP
1981-08-13Manufacturing (CMC) · Supplement 11 · standardAP
1980-09-12Labeling · Supplement 7 · standardAP
1980-06-03Manufacturing (CMC) · Supplement 8 · standardAP
1979-12-26Labeling · Supplement 10 · standardAP
1979-05-31Manufacturing (CMC) · Supplement 9 · standardAP
1977-09-26Manufacturing (CMC) · Supplement 6 · standardAP
1967-09-02Type 2 - New Active Ingredient · 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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