APPLICATION
ANDA076301
TYPE
ANDA
ORIGINAL APPROVAL
2004-06-25
LATEST ACTION
2011-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
LORATADINEOver-the-counter
LORATADINE 10MG · TABLET · ORAL
Approval history
2011-09-23Labeling · Supplement 25AP
2009-03-20Labeling · Supplement 21AP
2004-06-25OriginalAP
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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