Product Details for NDA 021312
CLARINEX (DESLORATADINE)
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DESLORATADINE
Proprietary Name: CLARINEX
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021312
Product Number: 002
Approval Date: Jul 14, 2005
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status: Discontinued
Patent and Exclusivity Information
CLARINEX (DESLORATADINE)
Proprietary Name: CLARINEX
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021312
Product Number: 002
Approval Date: Jul 14, 2005
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DESLORATADINE
Proprietary Name: CLARINEX
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021312
Product Number: 001
Approval Date: Jun 26, 2002
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CLARINEX
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021312
Product Number: 001
Approval Date: Jun 26, 2002
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status: Discontinued
Patent and Exclusivity Information