← FDA DRUG APPROVALS

FDA NDA · NDA019670

CLARITIN-D 12 HOUR

loratadine and pseudoephedrine sulfate

Sponsor: BAYER HEALTHCARE LLC

APPLICATION
NDA019670
TYPE
NDA
ORIGINAL APPROVAL
1994-11-14
LATEST ACTION
2023-11-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

CLARITIN-D · ReferenceOver-the-counter
LORATADINE 5MG, PSEUDOEPHEDRINE SULFATE 120MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-11-09Labeling · Supplement 36 · standard — Letter ↗AP
2018-07-31Labeling · Supplement 34 · standard — Letter ↗AP
2015-11-25Labeling · Supplement 32 · standard — Letter ↗AP
2013-10-18Manufacturing (CMC) · Supplement 31 · standardAP
2013-03-13Manufacturing (CMC) · Supplement 30 · standardAP
2010-01-25Labeling · Supplement 22 · unknown — Letter ↗AP
2009-04-23Manufacturing (CMC) · Supplement 20 — Review ↗AP
2004-07-30Efficacy · Supplement 19 · unknown — Label ↗AP
2002-11-27Efficacy · Supplement 18 · standard — Review ↗AP
2002-03-04Manufacturing (CMC) · Supplement 17 · standard — Review ↗AP
2000-11-01Manufacturing (CMC) · Supplement 15 · standard — Review ↗AP
2000-09-13Manufacturing (CMC) · Supplement 13 · standard — Review ↗AP
2000-03-22Manufacturing (CMC) · Supplement 14 · standard — Review ↗AP
1999-01-27Manufacturing (CMC) · Supplement 9 · standard — Review ↗AP
1998-10-29Manufacturing (CMC) · Supplement 12 · standard — Review ↗AP
1998-05-04Manufacturing (CMC) · Supplement 7 · standardAP
1998-04-29Labeling · Supplement 10 · standardAP
1998-01-23Manufacturing (CMC) · Supplement 8 · standard — Review ↗AP
1997-07-21Manufacturing (CMC) · Supplement 5 · standardAP
1997-07-14Labeling · Supplement 6 · standardAP
1997-02-07Manufacturing (CMC) · Supplement 1 · standardAP
1997-02-05Labeling · Supplement 4 · standardAP
1996-04-29Labeling · Supplement 3 · standardAP
1995-09-22Manufacturing (CMC) · Supplement 2 · standardAP
1994-11-14Type 4 - New Combination · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →