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FDA NDA · NDA020890

LOTRIMIN AF

Sponsor: SCHERING PLOUGH

APPLICATION
NDA020890
TYPE
NDA
ORIGINAL APPROVAL
1989-10-27
LATEST ACTION
2001-08-01
ROUTE
Topical
DOSAGE FORM
Solution
MARKETING STATUS
Over-the-counter

Products

LOTRIMIN AF · ReferenceOver-the-counter
CLOTRIMAZOLE 1% · Solution · Topical

Approval history

2001-08-01Labeling · Supplement 2 · standard — Label ↗AP
2001-03-12Manufacturing (CMC) · Supplement 4AP
2001-03-08Manufacturing (CMC) · Supplement 5AP
1998-10-26Manufacturing (CMC) · Supplement 1AP
1989-10-27UNKNOWN · Original · unknownAP
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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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