← FDA DRUG APPROVALS
FDA ANDA · ANDA075706
CLARITIN-D 24 HOUR
loratadine pseudoephedrine sulfate
Sponsor: P AND L
APPLICATION
ANDA075706
TYPE
ANDA
ORIGINAL APPROVAL
2003-02-21
LATEST ACTION
2004-11-26
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
2004-11-26Labeling · Supplement 6AP
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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