← FDA DRUG APPROVALS
FDA ANDA · ANDA076557
KIRKLAND SIGNATURE ALLERCLEAR D 24 HR EXTENDED RELEASE
loratadine and pseudoephedrine sulfate
Sponsor: SUN PHARM INDS LTD
APPLICATION
ANDA076557
TYPE
ANDA
ORIGINAL APPROVAL
2004-09-22
LATEST ACTION
2010-06-29
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
2010-06-29Labeling · Supplement 15AP
2005-09-20Labeling · Supplement 6AP
2005-04-13Labeling · Supplement 2AP
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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