← FDA DRUG APPROVALS
FDA NDA · NDA020470
CLARITIN-D 24 HOUR
loratadine and pseudoephedrine sulfate
Sponsor: BAYER HEALTHCARE LLC
APPLICATION
NDA020470
TYPE
NDA
ORIGINAL APPROVAL
1996-08-23
LATEST ACTION
2023-11-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter
Products
CLARITIN-D 24 HOUR · ReferenceOver-the-counter
LORATADINE 10MG, PSEUDOEPHEDRINE SULFATE 240MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2014-01-03Manufacturing (CMC) · Supplement 43 · standardAP
2013-04-26Manufacturing (CMC) · Supplement 41 · standardAP
2013-02-13Manufacturing (CMC) · Supplement 40 · standardAP
2002-12-09Manufacturing (CMC) · Supplement 17 · standardAP
2002-01-30Manufacturing (CMC) · Supplement 15 · standardAP
2000-09-13Manufacturing (CMC) · Supplement 12 · standardAP
2000-02-14Manufacturing (CMC) · Supplement 11 · standardAP
1999-10-01Manufacturing (CMC) · Supplement 9 · standardAP
1998-05-04Manufacturing (CMC) · Supplement 4 · standardAP
1997-10-06Labeling · Supplement 2 · standardAP
1997-03-26Labeling · Supplement 1 · standardAP
1996-08-23Type 3 - New Dosage Form · Original · standardAP
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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