APPLICATION
ANDA210088
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-16
LATEST ACTION
2025-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Over-the-counter
Products
LORATADINEOver-the-counter
LORATADINE 10MG · TABLET, CHEWABLE · ORAL
LORATADINEOver-the-counter
LORATADINE 5MG · TABLET, CHEWABLE · ORAL
Approval history
2025-04-25Manufacturing (CMC) · Supplement 15 · unknownAP
2023-10-13Labeling · Supplement 12 · standardAP
2020-03-05Labeling · Supplement 7 · standardAP
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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