Application 076183

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	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 24MG BASE	No	No
002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 8MG BASE	No	No
003	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 4MG BASE	No	No
004	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 16MG BASE	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8185	ondansetron hydrochloride	ondansetron hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8185	ondansetron hydrochloride	ondansetron hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8185	ondansetron hydrochloride	ondansetron hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6551	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6551	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6551	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6551	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6552	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6552	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6552	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6552	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
51662-1539	ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
55111-153	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-153	ondansetron hydrochloride	ondansetron hydrochloride	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-153	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-153	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-154	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-154	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-154	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-154	ondansetron hydrochloride	ondansetron hydrochloride	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-155	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-155	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-156	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-156	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-156	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-156	ondansetron hydrochloride	ondansetron hydrochloride	Dr.Reddy's Laboratories Limited	ANDA	Current
55154-7879	ondansetron hydrochloride	ondansetron hydrochloride	Cardinal Health	ANDA	Current
70518-1042	ondansetron hydrochloride	ondansetron hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1042	ondansetron hydrochloride	ondansetron hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents

Document	Submission type	Date
8874	ORIG	2007-01-08