APPLICATION
ANDA077421
TYPE
ANDA
ORIGINAL APPROVAL
2006-06-29
LATEST ACTION
2014-11-07
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Over-the-counter
Products
LORATADINEOver-the-counter
LORATADINE 1MG/ML · SYRUP · ORAL
Approval history
2014-11-07Manufacturing (CMC) · Supplement 8AP
2014-08-12Labeling · Supplement 4AP
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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