APPLICATION
ANDA077153
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-11
LATEST ACTION
2020-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Over-the-counter
Products
LORATADINE REDIDOSEOver-the-counter
LORATADINE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2020-03-03Labeling · Supplement 10 · standardAP
2014-01-26Labeling · Supplement 6AP
2007-04-11OriginalAP
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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