← FDA DRUG APPROVALS

FDA NDA · NDA020010

LOTRISONE

Sponsor: MERCK SHARP DOHME

APPLICATION
NDA020010
TYPE
NDA
ORIGINAL APPROVAL
2000-12-08
LATEST ACTION
2009-05-11
ROUTE
TOPICAL
DOSAGE FORM
LOTION
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DIPROPIONATE EQ 0.05% BASE, CLOTRIMAZOLE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LOTION · TOPICAL

Approval history

2009-05-11Labeling · Supplement 21 · standard — Letter ↗AP
2008-12-18Labeling · Supplement 20 · standard — Letter ↗AP
2008-01-25Labeling · Supplement 15 · standard — Label ↗AP
2006-04-24Labeling · Supplement 11 · standard — Letter ↗AP
2003-03-27Labeling · Supplement 5 · standard — Label ↗AP
2002-12-17Labeling · Supplement 3 · standard — Label ↗AP
2002-04-04Manufacturing (CMC) · Supplement 2 · standardAP
2002-01-10Manufacturing (CMC) · Supplement 1 · standardAP
2000-12-08Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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