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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 021313


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NDA 021313 describes CLARINEX-D 12 HOUR, which is a drug marketed by Organon Llc and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.
Summary for 021313
Tradename:CLARINEX-D 12 HOUR
Applicant:Organon Llc
Ingredient:desloratadine; pseudoephedrine sulfate
Patents:0
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 Organon LLC 78206-120 78206-120-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (78206-120-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG;120MG
Approval Date:Feb 1, 2006TE:RLD:Yes

Expired US Patents for NDA 021313

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Llc CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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