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FDA ANDA · ANDA076050
ALLERGY AND CONGESTION RELIEF
loratadine, pseudoephedrine sulfate
Sponsor: PERRIGO PHARMA INTL
APPLICATION
ANDA076050
TYPE
ANDA
ORIGINAL APPROVAL
2003-01-30
LATEST ACTION
2014-10-21
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter
Products
LORATADINE AND PSEUDOEPHEDRINE SULFATEOver-the-counter
LORATADINE 5MG, PSEUDOEPHEDRINE SULFATE 120MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2014-10-21Manufacturing (CMC) · Supplement 21AP
2005-06-21Labeling · Supplement 11AP
2004-09-22Labeling · Supplement 7AP
2004-07-28Labeling · Supplement 5AP
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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