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Details for New Drug Application (NDA): 021605

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NDA 021605 describes CLARINEX D 24 HOUR, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are four patents protecting this drug. Additional details are available on the CLARINEX D 24 HOUR profile page.

The generic ingredient in CLARINEX D 24 HOUR is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.

Summary for NDA: 021605

Tradename:
CLARINEX D 24 HOUR
Applicant:
Merck Sharp Dohme
Ingredient:
desloratadine; pseudoephedrine sulfate
Patents:4
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;240MG
Approval Date:Mar 3, 2005TE:ABRLD:Yes
Patent:6,100,274*PEDPatent Expiration:Jan 7, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:6,979,463Patent Expiration:Mar 28, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:7,618,649*PEDPatent Expiration:Jun 19, 2021Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021605

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 20054,659,716*PED► subscribe
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 20057,214,684*PED► subscribe
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 20057,214,683*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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