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Details for Generic Name: loratadine; pseudoephedrine sulfate

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Loratadine; pseudoephedrine sulfate is the generic ingredient in three branded drugs marketed by Bayer Healthcare Llc, Actavis Labs Fl Inc, Impax Labs, and Sun Pharm Inds Ltd, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-nine drug master file entries for loratadine; pseudoephedrine sulfate. One supplier is listed for this compound.

Summary for Generic Name: loratadine; pseudoephedrine sulfate

Tradenames:3
Patents:0
Applicants:4
NDAs:7
Drug Master File Entries: see list39
Suppliers: see list1
Formulation / Manufacturing:see details

Clinical Trials for: loratadine; pseudoephedrine sulfate

Bioequivalnce Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fed Conditions
Status: Completed Condition: Healthy

Clinical Trial Of The Effectiveness Of The Product Cloratadd D (Loratadine + Pseudoephedrine Sulfate) Produced By The Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With Allergic Rhinitis
Status: Withdrawn Condition: Allergic Rhinitis

Comparative Effectiveness of Two Associations of Loratadine + Pseudoephedrine, Cloratadd-d ® (Coated Pill) Produced by the Laboratory Ems and Claritin-d ® (dräger), Produced by Schering-plough in Patients With Perennial Allergic Rhinitis
Status: Completed Condition: Perennial Allergic Rhinitis

Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED)
Status: Completed Condition: Rhinitis, Allergic, Seasonal

Effect of Loratadine/Montelukast Combination on Congestion in SAR Patients Exposed to Pollen in an EEU (Study P04822)
Status: Completed Condition: Seasonal Allergic Rhinitis

Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1)
Status: Completed Condition: Seasonal Allergic Rhinitis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Fl Inc
LORATADINE AND PSEUDOEPHEDRINE SULFATE
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL076208-001Jan 28, 2004DISCNNo<disabled><disabled>
Bayer Healthcare Llc
CLARITIN-D 24 HOUR
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL020470-002Nov 27, 2002OTCYes<disabled><disabled>
Impax Labs
LORATADINE AND PSEUDOEPHEDRINE SULFATE
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL076050-001Jan 30, 2003OTCNo<disabled><disabled>
Bayer Healthcare Llc
CLARITIN-D
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL019670-002Nov 27, 2002OTCYes<disabled><disabled>
Actavis Labs Fl Inc
LORATADINE AND PSEUDOEPHEDRINE SULFATE
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL075706-001Feb 21, 2003OTCNo<disabled><disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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