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FDA ANDA · ANDA076134
LORATADINE ALLERGY RELIEF
loratadine
Sponsor: SUN PHARM INDS LTD
APPLICATION
ANDA076134
TYPE
ANDA
ORIGINAL APPROVAL
2003-08-18
LATEST ACTION
2009-03-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
LORATADINEOver-the-counter
LORATADINE 10MG · TABLET · ORAL
Approval history
2009-03-24Labeling · Supplement 19AP
2007-04-16Labeling · Supplement 8AP
2007-03-23Manufacturing (CMC) · Supplement 15AP
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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