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Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021313

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NDA 021313 describes CLARINEX-D 12 HOUR, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the CLARINEX-D 12 HOUR profile page.

The generic ingredient in CLARINEX-D 12 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 021313
Tradename:CLARINEX-D 12 HOUR
Applicant:Merck Sharp Dohme
Ingredient:desloratadine; pseudoephedrine sulfate
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 021313
Suppliers and Packaging for NDA: 021313
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313 NDA Merck Sharp & Dohme Corp. 0085-1322 N 0085-1322-01
CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313 NDA Physicians Total Care, Inc. 54868-5708 E 54868-5708-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG;120MG
Approval Date:Feb 1, 2006TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 7, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Feb 18, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:ALLERGIC RHINITIS
Patent:➤ Try a Free TrialPatent Expiration:Jun 19, 2021Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021313

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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