Application 075682

Type: ANDA
Sponsor: DR REDDYS LA

Related Records

Company: DR REDDYS LA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	400MG	No	No
002	IBUPROFEN	IBUPROFEN	TABLET;ORAL	600MG	No	No
003	IBUPROFEN	IBUPROFEN	TABLET;ORAL	800MG	No	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8115	IBU	Ibuprofen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8115	IBU	Ibuprofen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8116	IBU	Ibuprofen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8116	IBU	Ibuprofen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8117	IBU	Ibuprofen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8117	IBU	Ibuprofen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-5853	Ibuprofen	Ibuprofen	Major Pharmaceuticals	ANDA	Current
0904-5853	Ibuprofen	Ibuprofen	Major Pharmaceuticals	ANDA	Current
0904-5854	Ibuprofen	Ibuprofen	Major Pharmaceuticals	ANDA	Current
0904-5854	Ibuprofen	Ibuprofen	Major Pharmaceuticals	ANDA	Current
0904-5855	Ibuprofen	Ibuprofen	Major Pharmaceuticals	ANDA	Current
0904-5855	Ibuprofen	Ibuprofen	Major Pharmaceuticals	ANDA	Current
10544-071	IBU	Ibuprofen	Blenheim Pharmacal, Inc.	ANDA	Current
10544-625	IBU	Ibuprofen	Blenheim Pharmacal, Inc.	ANDA	Current
12634-171	IBUPROFEN	Ibuprofen	Apotheca Inc.	ANDA	Current
12634-191	IBUPROFEN	Ibuprofen	Apotheca Inc.	ANDA	Current
12634-682	IBUPROFEN	Ibuprofen	Apotheca Inc.	ANDA	Current
21695-066	Ibuprofen	Ibuprofen	Rebel Distributors Corp	ANDA	Current
21695-067	Ibuprofen	Ibuprofen	Rebel Distributors Corp	ANDA	Current
21695-068	Ibuprofen	Ibuprofen	Rebel Distributors Corp	ANDA	Current
35356-699	IBU	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-699	IBU	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
43353-095	Ibuprofen	Ibuprofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-095	Ibuprofen	Ibuprofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-273	IBU	Ibuprofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-314	Ibuprofen	Ibuprofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-314	Ibuprofen	Ibuprofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-4331	IBU	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-4333	IBU	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-4339	IBU	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-4341	IBU	Ibuprofen	A-S Medication Solutions	ANDA	Current
50436-0684	IBU	Ibuprofen	Unit Dose Services	ANDA	Current
50436-4604	IBU	Ibuprofen	Unit Dose Services	ANDA	Current
50436-4605	IBU	Ibuprofen	Unit Dose Services	ANDA	Current
51407-369	IBU	Ibuprofen	Golden State Medical Supply, Inc.	ANDA	Current
51407-370	IBU	Ibuprofen	Golden State Medical Supply, Inc.	ANDA	Current
51407-371	IBU	Ibuprofen	Golden State Medical Supply, Inc.	ANDA	Current
51655-851	Ibuprofen	Ibuprofen	Northwind Pharmaceuticals	ANDA	Current
53002-3010	IBU	Ibuprofen	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3010	IBU	Ibuprofen	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3370	IBU	Ibuprofen	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3370	IBU	Ibuprofen	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3980	IBU	Ibuprofen	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3980	IBU	Ibuprofen	RPK Pharmaceuticals, Inc.	ANDA	Current
53217-366	IBU	Ibuprofen	Aidarex Pharmaceuticals LLC	ANDA	Current
55111-682	IBU	Ibuprofen	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-682	IBU	Ibuprofen	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-683	IBU	Ibuprofen	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-683	IBU	Ibuprofen	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-684	IBU	Ibuprofen	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-684	IBU	Ibuprofen	Dr. Reddy's Laboratories Limited	ANDA	Current
55154-0741	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-0741	Ibuprofen	Ibuprofen	Cardinal Health 107, LLC	ANDA	Current
55154-0741	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-0741	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-1342	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-1342	Ibuprofen	Ibuprofen	Cardinal Health 107, LLC	ANDA	Current
55154-1342	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-1342	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-1380	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-1380	Ibuprofen	Ibuprofen	Cardinal Health 107, LLC	ANDA	Current
55154-1380	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-1380	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
59088-703	PharmapureRx IBU 600-EZS	ibuprofen	PureTek Corporation	ANDA	Current
60429-219	IBU	Ibuprofen	Golden State Medical Supply, Inc.	ANDA	Current
60429-219	IBU	Ibuprofen	Golden State Medical Supply, Inc.	ANDA	Current
60429-220	IBU	Ibuprofen	Golden State Medical Supply, Inc.	ANDA	Current
60429-220	IBU	Ibuprofen	Golden State Medical Supply, Inc.	ANDA	Current
60429-221	IBU	Ibuprofen	Golden State Medical Supply, Inc.	ANDA	Current
60429-221	IBU	Ibuprofen	Golden State Medical Supply, Inc.	ANDA	Current
60760-076	IBU	Ibuprofen	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-076	IBU	Ibuprofen	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-135	IBU	Ibuprofen	St. Mary	ANDA	Current
61919-621	IBU	IBU	Direct_Rx	ANDA	Current
61919-621	IBUPROFEN	IBUPROFEN	Direct_Rx	ANDA	Current
61919-621	IBUPROFEN	IBUPROFEN	Direct_Rx	ANDA	Current
61919-621	IBUPROFEN	IBUPROFEN	Direct_Rx	ANDA	Current
61919-621	IBU	IBU	Direct_Rx	ANDA	Current
61919-621	IBU	IBU	Direct _Rx	ANDA	Current
61919-621	IBU	IBU	Direct_Rx	ANDA	Current

Documents

Document	Title	Submission type	Submission no.	Date
22495	0	ORIG	1	2005-07-22
8763	0	ORIG	1	2003-04-14