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Details for New Drug Application (NDA): 021300

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NDA 021300 describes CLARINEX, which is a drug marketed by Merck Sharp Dohme and is included in five NDAs. It is available from two suppliers. There are nine patents protecting this drug and four Paragraph IV challenges. Additional details are available on the CLARINEX profile page.

The generic ingredient in CLARINEX 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: 021300

Tradename:
CLARINEX
Applicant:
Merck Sharp Dohme
Ingredient:
desloratadine
Patents:1
Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 021300

Suppliers and Packaging for NDA: 021300

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARINEX
desloratadine
SOLUTION;ORAL 021300 NDA Merck Sharp & Dohme Corp. 0085-1334 0085-1334-01 1 BOTTLE in 1 CARTON (0085-1334-01) > 473 mL in 1 BOTTLE
CLARINEX
desloratadine
SOLUTION;ORAL 021300 NDA Merck Sharp & Dohme Corp. 0085-1334 0085-1334-02 1 BOTTLE in 1 CARTON (0085-1334-02) > 118 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength0.5MG/ML
Approval Date:Sep 1, 2004TE:AARLD:Yes
Patent:6,514,520*PEDPatent Expiration:Dec 1, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021300

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
CLARINEX
desloratadine
SOLUTION;ORAL021300-001Sep 1, 20044,659,716*PED► subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
SOLUTION;ORAL021300-001Sep 1, 20047,214,684*PED► subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
SOLUTION;ORAL021300-001Sep 1, 20047,214,683*PED► subscribe
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