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FDA NDA · NDA018827

LOTRISONE

Sponsor: ORGANON

APPLICATION
NDA018827
TYPE
NDA
ORIGINAL APPROVAL
1984-07-10
LATEST ACTION
2019-06-14
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

LOTRISONE · ReferenceDiscontinued
BETAMETHASONE DIPROPIONATE EQ 0.05% BASE, CLOTRIMAZOLE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

2019-06-14Labeling · Supplement 50 · standard — Letter ↗AP
2018-05-21Labeling · Supplement 49 · standard — Label ↗AP
2014-04-21Labeling · Supplement 46 · standard — Letter ↗AP
2009-05-11Labeling · Supplement 42 · standard — Letter ↗AP
2008-01-25Labeling · Supplement 38 · standard — Letter ↗AP
2003-03-27Labeling · Supplement 25 · standard — Label ↗AP
2002-01-10Manufacturing (CMC) · Supplement 24 · standardAP
2001-10-03Labeling · Supplement 9AP
2001-10-03Labeling · Supplement 7 — Label ↗AP
2001-10-03Efficacy · Supplement 22 · standard — Letter ↗AP
2001-10-03Labeling · Supplement 20 · standardAP
2001-02-28Manufacturing (CMC) · Supplement 21 · standardAP
2000-02-02Manufacturing (CMC) · Supplement 19 · standardAP
1999-05-14Manufacturing (CMC) · Supplement 18 · standardAP
1998-11-10Manufacturing (CMC) · Supplement 17 · standardAP
1998-07-31Manufacturing (CMC) · Supplement 15 · standardAP
1998-06-15Manufacturing (CMC) · Supplement 14 · standardAP
1998-05-18Manufacturing (CMC) · Supplement 16 · standardAP
1995-01-30Manufacturing (CMC) · Supplement 12 · standardAP
1995-01-30Manufacturing (CMC) · Supplement 11 · standardAP
1994-10-06Manufacturing (CMC) · Supplement 10 · standardAP
1990-09-11Manufacturing (CMC) · Supplement 8 · standardAP
1990-08-01Manufacturing (CMC) · Supplement 6 · standardAP
1987-10-29Manufacturing (CMC) · Supplement 5 · standardAP
1986-09-12Manufacturing (CMC) · Supplement 4 · standardAP
1986-05-20Manufacturing (CMC) · Supplement 3 · standardAP
1986-04-23Manufacturing (CMC) · Supplement 2 · standardAP
1985-02-22Manufacturing (CMC) · Supplement 1 · standardAP
1984-07-10Type 4 - New Combination · Original · standardAP
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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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