Application 078343

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Related Records

Company: DR REDDYS LABS LTD

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-811	Cetirizine Hydrochloride	Cetirizine Hydrochloride Tablets	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-811	Cetirizine Hydrochloride	Cetirizine Hydrochloride Tablets	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-811	Cetirizine Hydrochloride	Cetirizine Hydrochloride Tablets	Dr. Reddy's Laboratories Inc.	ANDA	Current
49035-010	Allergy Relief	Cetirizine Hydrochloride Tablets	Wal-Mart Stores Inc	ANDA	Current
53943-519	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Discount Drug Mart, Inc	ANDA	Current
55111-351	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-699	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Dr.Reddy's Laboratories Limited	ANDA	Current
62011-0307	cetirizine hydrochloride	Cetirizine Hydrochloride Tablets	Strategic Sourcing Services LLC	ANDA	Current
62011-0307	cetirizine hydrochloride	Cetirizine Hydrochloride Tablets	MCKESSON	ANDA	Current
62011-0307	cetirizine hydrochloride	Cetirizine Hydrochloride Tablets	Strategic Sourcing Services LLC	ANDA	Current
62011-0307	cetirizine hydrochloride	Cetirizine Hydrochloride Tablets	Strategic Sourcing Services LLC	ANDA	Current
62011-0414	cetirizine hydrochloride	Cetirizine Hydrochloride Tablets	Strategic Sourcing Services LLC	ANDA	Current
62011-0414	cetirizine hydrochloride	Cetirizine Hydrochloride Tablets	Strategic Sourcing Services LLC	ANDA	Current
62011-0414	cetirizine hydrochloride	Cetirizine Hydrochloride Tablets	Strategic Sourcing Services LLC	ANDA	Current
68071-2570	Cetirizine Hydrochloride	Cetirizine Hydrochloride Tablets	NuCare Pharmaceuticals,Inc.	ANDA	Current
69842-867	Allergy Relief	Cetirizine Hydrochloride Tablets	CVS Health Corp.	ANDA	Current
70518-3468	Cetirizine Hydrochloride	Cetirizine Hydrochloride Tablets	REMEDYREPACK INC.	ANDA	Current
70518-3468	Cetirizine Hydrochloride	Cetirizine Hydrochloride Tablets	REMEDYREPACK INC.	ANDA	Current
70518-3468	Cetirizine Hydrochloride	Cetirizine Hydrochloride Tablets	REMEDYREPACK INC.	ANDA	Current
70518-3468	Cetirizine Hydrochloride	Cetirizine Hydrochloride Tablets	REMEDYREPACK INC.	ANDA	Current
70677-0142	cetirizine hydrochloride	Cetirizine Hydrochloride Tablets	Strategic Sourcing Services LLC	ANDA	Current
70677-0142	cetirizine hydrochloride	Cetirizine Hydrochloride Tablets	Strategic Sourcing Services LLC	ANDA	Current
71205-709	Cetirizine Hydrochloride	Cetirizine Hydrochloride Tablets	Proficient Rx LP	ANDA	Current
71335-9612	Cetirizine Hydrochloride	Cetirizine Hydrochloride Tablets	Bryant Ranch Prepack	ANDA	Current

Documents

Document	Submission type	Date
39557	ORIG	2008-01-23
31358	ORIG	2008-01-17