ACTIVE SUBSTANCE / INN

DESLORATADINE

Brand name(s): Neoclarityn, Allex, Dasselta, Desloratadine ratiopharm, DESLORATADINE, CLARINEX D 24 HOUR, CLARINEX-D 12 HOUR, Desloratadine Actavis, Opulis, Aerius, DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, Azomyr, Desloratadine Teva, Desloratadine Krka, CLARINEX

FDA LISTED

EMA LISTED

DISCONTINUED

PRESCRIPTION

WITHDRAWN

Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, …

NDA021297

FDA APPLICATIONS (DRUGS@FDA)

BRAND NAME	APPLICATION	SPONSOR	STATUS
DESLORATADINE	ANDA078362	GLENMARK GENERICS	None (Tentative Approval)
CLARINEX-D 12 HOUR	NDA021313	ORGANON LLC	Prescription
DESLORATADINE	ANDA202936	TARO	Prescription
CLARINEX	NDA021297	SCHERING	Prescription
CLARINEX	NDA021312	ORGANON	Discontinued
DESLORATADINE	ANDA078359	SUN PHARM INDS	Discontinued
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR	ANDA078366	DR REDDYS LABS LTD	Prescription
CLARINEX D 24 HOUR	NDA021605	ORGANON	Discontinued

EMA AUTHORISATIONS

PRODUCT NAME	HOLDER	STATUS	DATE	INDICATION
Neoclarityn	Organon N.V.	Authorised	15/01/2001	Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, Seasonal
Azomyr	Organon N.V.	Authorised	15/01/2001	Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, Seasonal
Aerius	Organon N.V.	Authorised	15/01/2001	Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, Seasonal
Desloratadine Actavis	Actavis Group PTC ehf	Authorised	13/01/2012	Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, Seasonal
Desloratadine ratiopharm	Ratiopharm GmbH	Authorised	13/01/2012	Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, Seasonal
Desloratadine Teva	Teva B.V	Authorised	24/11/2011	Rhinitis, Allergic, Perennial;Rhinitis, Allergic, Seasonal
Dasselta	Krka, d.d., Novo mesto	Authorised	28/11/2011	Rhinitis, Allergic, Perennial;Rhinitis, Allergic, Seasonal;Urticaria
Desloratadine Krka	Krka, d.d., Novo mesto	Application withdrawn		Rhinitis, Allergic, Perennial;Rhinitis, Allergic, Seasonal
Allex	Schering-Plough Europe	Withdrawn	15/01/2001	Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, Seasonal
Opulis	Schering-Plough Europe	Withdrawn	15/01/2001	Rhinitis, Allergic, Perennial;Urticaria;Rhinitis, Allergic, Seasonal

DESLORATADINE

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