APPLICATION
NDA019155
TYPE
NDA
ORIGINAL APPROVAL
1985-04-24
LATEST ACTION
2013-04-02
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued
Products
LAC-HYDRIN · ReferenceDiscontinued
AMMONIUM LACTATE EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LOTION · TOPICAL
Approval history
2013-04-02Manufacturing (CMC) · Supplement 30 · standardAP
1998-05-20Manufacturing (CMC) · Supplement 18 · standardAP
1997-12-08Manufacturing (CMC) · Supplement 16 · standardAP
1997-12-08Manufacturing (CMC) · Supplement 17 · standardAP
1995-05-08Manufacturing (CMC) · Supplement 13 · standardAP
1995-05-05Manufacturing (CMC) · Supplement 12 · standardAP
1995-01-04Manufacturing (CMC) · Supplement 11 · standardAP
1993-02-19Manufacturing (CMC) · Supplement 10 · standardAP
1992-07-16Manufacturing (CMC) · Supplement 9 · standardAP
1992-03-26Manufacturing (CMC) · Supplement 8 · standardAP
1990-11-19Manufacturing (CMC) · Supplement 7 · standardAP
1989-09-15Manufacturing (CMC) · Supplement 6 · standardAP
1988-02-19Manufacturing (CMC) · Supplement 5 · standardAP
1987-06-18Manufacturing (CMC) · Supplement 4 · standardAP
1986-03-27Labeling · Supplement 3AP
1985-08-09Manufacturing (CMC) · Supplement 2 · standardAP
1985-08-09Manufacturing (CMC) · Supplement 1 · standardAP
1985-04-24Type 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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