Application 076200

Type: ANDA
Sponsor: OHM LABS

Related Records

Company: OHM LABS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN	ACETAMINOPHEN	TABLET, EXTENDED RELEASE;ORAL	650MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0334	Acetaminophen	Acetaminophen	Walgreen Company	ANDA	Current
0363-0336	Acetaminophen	Acetaminophen	Walgreen Company	ANDA	Current
0363-0336	Acetaminophen	Acetaminophen	Walgreen Company	ANDA	Current
0363-0336	Acetaminophen	Acetaminophen	Walgreen Company	ANDA	Current
0615-8404	Arthritis Pain Reliever	Acetaminophen	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8404	Arthritis Pain Reliever	Acetaminophen	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8404	Arthritis Pain Reliever	Acetaminophen	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
15127-332	Acetaminophen	Acetaminophen	Select Brand	ANDA	Current
21130-336	Arthritis 8 Hour	Acetaminophen	Safeway Inc.	ANDA	Current
21130-760	Acetaminophen	Acetaminophen	Safeway Inc.	ANDA	Current
21130-760	Acetaminophen	Acetaminophen	Safeway Inc.	ANDA	Current
30142-968	Acetaminophen	ACETAMINOPHEN	The Kroger Company	ANDA	Current
30142-968	Acetaminophen	ACETAMINOPHEN	The Kroger Company	ANDA	Current
30142-968	Acetaminophen	ACETAMINOPHEN	The Kroger Company	ANDA	Current
30142-970	Arthritis Pain Reliever	Acetaminophen	The Kroger Company	ANDA	Current
33261-665	Arthritis Pain Reliever	Acetaminophen	Aidarex Pharmaceuticals LLC	ANDA	Current
36800-228	Topco Arthritis 8 Hour	Acetaminophen	Topco Associates LLC	ANDA	Current
37012-333	Acetaminophen	Acetaminophen	Shopko Stores Operating Co., LLC	ANDA	Current
37205-034	Leader Arthritis Pain Reliever	Acetaminophen	Cardinal Health	ANDA	Current
37205-477	Leader 8 Hour Pain Reliever	Acetaminophen	Cardinal Health	ANDA	Current
37808-333	Acetaminophen	Acetaminophen	H-E-B	ANDA	Current
41163-333	Acetaminophen	Acetaminophen	SUPERVALU INC.	ANDA	Current
41163-336	Acetaminophen 8 Hour	Acetaminophen	Supervalu Inc.	ANDA	Current
41520-333	Acetaminophen	Acetaminophen	American Sales Company	ANDA	Current
41520-336	Acetaminophen-APAP 8 Hour	Acetaminophen	American Sales Company	ANDA	Current
46122-062	Acetaminophen	Acetaminophen	Amerisource Bergen	ANDA	Current
46122-062	Acetaminophen	Acetaminophen	Amerisource Bergen	ANDA	Current
46122-062	Acetaminophen	Acetaminophen	Amerisource Bergen	ANDA	Current
46122-062	Acetaminophen	Acetaminophen	Amerisource Bergen	ANDA	Current
46122-062	Acetaminophen	Acetaminophen	Amerisource Bergen	ANDA	Current
46122-170	Acetaminophen	Acetaminophen	Amerisource Bergen	ANDA	Current
46122-170	Acetaminophen	Acetaminophen	Amerisource Bergen	ANDA	Current
49348-921	Sunmark Arthritis Pain Reliever	Acetaminophen	Sunmark	ANDA	Current
49348-924	Sunmark Arthritis 8 Hour	Acetaminophen	Sunmark	ANDA	Current
49614-473	Medicine Shoppe Arthritis Pain Reliever	Acetaminophen	The Medicine Shoppe International	ANDA	Current
50268-052	Arthritis Pain Reliever	Acetaminophen	AvPAK	ANDA	Current
50268-052	Arthritis Pain Reliever	Acetaminophen	AvPAK	ANDA	Current
50268-052	Arthritis Pain Reliever	Acetaminophen	AvPAK	ANDA	Current
51660-333	Arthritis Pain Reliever	Acetaminophen	Ohm Laboratories Inc.	ANDA	Current
51660-333	Arthritis Pain Reliever	Acetaminophen	Ohm Laboratories Inc.	ANDA	Current
51660-333	Arthritis Pain Reliever	Acetaminophen	Ohm Laboratories Inc.	ANDA	Current
51660-333	Arthritis Pain Reliever	Acetaminophen	Ohm Laboratories Inc.	ANDA	Current
53329-643	Acetaminophen	Acetaminophen	Medline Industries, LP	ANDA	Current
53329-643	Acetaminophen	Acetaminophen	Medline Industries, LP	ANDA	Current
53329-643	Acetaminophen	Acetaminophen	Medline Industries, Inc.	ANDA	Current
53329-643	Acetaminophen	Acetaminophen	Medline Industries, Inc.	ANDA	Current
53329-643	Acetaminophen	Acetaminophen	Medline Industries, Inc.	ANDA	Current
53329-643	Acetaminophen	Acetaminophen	Medline Industries, Inc.	ANDA	Current
55315-333	Acetaminophen	Acetaminophen	Fred's Inc.	ANDA	Current
55315-333	Acetaminophen	Acetaminophen	Fred's Inc.	ANDA	Current
55319-333	Acetaminophen	Acetaminophen	Family Dollar Services, Inc.	ANDA	Current
55319-333	Acetaminophen	Acetaminophen	Family Dollar Services, Inc.	ANDA	Current
55319-333	Acetaminophen	Acetaminophen	Family Dollar Services, Inc.	ANDA	Current
55319-333	Acetaminophen	Acetaminophen	Family Dollar Services, Inc.	ANDA	Current
55319-333	Acetaminophen	Acetaminophen	Family Dollar Services, I	ANDA	Current
55700-679	Arthritis Pain Reliever	Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-679	Arthritis Pain Reliever	Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-679	Arthritis Pain Reliever	Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
59779-336	Acetaminophen 8 Hour	Acetaminophen	CVS Pharmacy	ANDA	Current
59779-350	Acetaminophen	Acetaminophen	CVS Pharmacy	ANDA	Current
59779-350	Acetaminophen	Acetaminophen	CVS Pharmacy	ANDA	Current
61919-860	ACETAMINOPHEN	ACETAMINOPHEN	DirectRX	ANDA	Current
62011-0026	Acetaminophen	Acetaminophen	Health Mart	ANDA	Current
63868-089	Acetaminophen	Acetaminophen	Chain Drug Marketing Association Inc.	ANDA	Current
63868-089	Acetaminophen	Acetaminophen	Chain Drug Marketing Association Inc.	ANDA	Current
63868-091	Acetaminophen	Acetaminophen	Chain Drug Marketing Association Inc.	ANDA	Current
63868-091	Acetaminophen	Acetaminophen	Chain Drug Marketing Association Inc.	ANDA	Current
63941-333	Acetaminophen - APAP Arthritis	Acetaminophen	Valu Merchandisers Company	ANDA	Current
63941-333	Acetaminophen - APAP Arthritis	Acetaminophen	Valu Merchandisers Company	ANDA	Current
63941-336	Acetaminophen - APAP 8 Hour	Acetaminophen	Valu Merchandisers Company	ANDA	Current
63941-336	Acetaminophen - APAP 8 Hour	Acetaminophen	Valu Merchandisers Company	ANDA	Current
66336-233	Arthritis Pain Reliever	Acetaminophen	Dispensing Solutions, Inc.	ANDA	Current
68016-333	Premier Value Arthritis Pain Reliever	Acetaminophen	Chain Drug Consortium, LLC.	ANDA	Current
68016-333	Premier Value Arthritis Pain Reliever	Acetaminophen	Chain Drug Consortium, LLC.	ANDA	Current
68016-336	Premier Value Arthritis 8 Hour	Acetaminophen	Premier Value	ANDA	Current
68016-336	Premier Value Arthritis 8 Hour	Acetaminophen	Premier Value	ANDA	Current
68071-1552	Arthritis Pain Reliever	Acetaminophen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1552	Arthritis Pain Reliever	Acetaminophen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1552	Arthritis Pain Reliever	Acetaminophen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68084-777	Arthritis Pain Reliever	Acetaminophen	American Health Packaging	ANDA	Current

Documents

Document	Submission type	Submission no.	Date	Storage
43064	SUPPL	4	2007-06-11	FDA source fallback
43063	SUPPL	2	2007-06-11	FDA source fallback
22547	SUPPL	5	2007-06-11	FDA source fallback
22546	SUPPL	3	2007-06-11	FDA source fallback
43062	SUPPL	1	2006-04-20	FDA source fallback
22545	ORIG	1	2006-04-20	FDA source fallback
8876	ORIG	1	2002-03-19	FDA source fallback