← FDA DRUG APPROVALS

FDA NDA · NDA021375

ALAVERT ALLERGY

loratadine

Sponsor: FDN CONSUMER

APPLICATION
NDA021375
TYPE
NDA
ORIGINAL APPROVAL
2002-12-19
LATEST ACTION
2005-08-19
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Over-the-counter

Products

ALAVERTOver-the-counter
LORATADINE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2005-08-19Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP
2002-12-19Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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