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FDA ANDA · ANDA075989
ALLERGY CONGESTION RELIEF
loratadine, pseudoephedrine sulfate
Sponsor: PERRIGO PHARMA INTL
APPLICATION
ANDA075989
TYPE
ANDA
ORIGINAL APPROVAL
2004-03-04
LATEST ACTION
2009-03-27
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter
Products
LORATADINE AND PSEUDOEPHEDRINE SULFATEOver-the-counter
LORATADINE 10MG, PSEUDOEPHEDRINE SULFATE 240MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2009-03-27Labeling · Supplement 9AP
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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