Application 079096

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Related Records

Company: AMNEAL PHARMS NY

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN SODIUM	NAPROXEN SODIUM	TABLET;ORAL	220MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0168	All Day Pain Relief	Naproxen Sodium	Walgreens	ANDA	Current
0363-0168	All Day Pain Relief	Naproxen Sodium	Walgreens	ANDA	Current
0363-0168	All Day Pain Relief	Naproxen Sodium	Walgreens	ANDA	Current
0363-0169	All Day Pain Relief	Naproxen Sodium	Walgreens	ANDA	Current
0363-0169	All Day Pain Relief	Naproxen Sodium	Walgreens	ANDA	Current
0363-0169	All Day Pain Relief	Naproxen Sodium	Walgreens	ANDA	Current
15127-168	All Day Pain Relief	Naproxen Sodium	Select Brand Dist.	ANDA	Current
15127-168	All Day Pain Relief	Naproxen Sodium	Select Brand Dist.	ANDA	Current
15127-168	All Day Pain Relief	Naproxen Sodium	Select Brand Dist.	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
27854-103	Flanax Pain Reliever	Naproxen Sodium	Belmora LLC	ANDA	Current
30142-168	All Day Pain Relief	Naproxen Sodium	The Kroger Co.	ANDA	Current
33992-0169	All Day Pain Relief	Naproxen Sodium	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
33992-0169	All Day Pain Relief	Naproxen Sodium	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
33992-0169	All Day Pain Relief	Naproxen Sodium	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
37205-744	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 37205	ANDA	Current
37808-068	All Day Pain Relief	Naproxen Sodium	H E B	ANDA	Current
37808-068	All Day Pain Relief	Naproxen Sodium	H E B	ANDA	Current
37808-068	All Day Pain Relief	Naproxen Sodium	H E B	ANDA	Current
37808-068	All Day Pain Relief	Naproxen Sodium	H E B	ANDA	Current
37808-068	All Day Pain Relief	Naproxen Sodium	H E B	ANDA	Current
41163-167	All Day Pain Relief	Naproxen Sodium	EQUALINE (SuperValu)	ANDA	Current
41163-167	All Day Pain Relief	Naproxen Sodium	EQUALINE (SuperValu)	ANDA	Current
41163-169	All Day Pain Relief	Naproxen Sodium	SuperValu (Equaline)	ANDA	Current
41163-169	All Day Pain Relief	Naproxen Sodium	EQUALINE (SuperValu)	ANDA	Current
42961-108	First Aid Direct Naproxen Sodium	Naproxen Sodium	Cintas Corp	ANDA	Current
47682-037	Belmora Flanax	Naproxen Sodium	Unifirst First Aid Corporation	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corpor	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	ANDA	Current
47682-237	Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	ANDA	Current
47682-737	Medique at Home Mediproxen	Naproxen Sodium	Unifirst First Aid Corporation	ANDA	Current
47682-737	Medique at Home Mediproxen	Naproxen Sodium	Unifirst First Aid Corporation	ANDA	Current
47682-737	Medique at Home Mediproxen	Naproxen Sodium	Unifirst First Aid Corporation	ANDA	Current
47682-737	Medique at Home Mediproxen	Naproxen Sodium	Unifirst First Aid Corporation	ANDA	Current
49035-068	Naproxen Sodium	Naproxen Sodium	EQUATE (Walmart Stores, Inc.)	ANDA	Current
49035-068	Naproxen Sodium	Naproxen Sodium	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49781-046	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-046	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-047	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-047	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-145	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-145	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-146	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
49781-146	All Day Pain Relief	Naproxen Sodium	Cardinal Health (Leader) 49781	ANDA	Current
50090-2388	Medique Mediproxen	NAPROXEN SODIUM	A-S Medication Solutions	ANDA	Current
50090-2388	Medique Mediproxen	NAPROXEN SODIUM	A-S Medication Solutions	ANDA	Current
50090-2388	Medique Mediproxen	NAPROXEN SODIUM	A-S Medication Solutions	ANDA	Current
50844-271	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-271	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-271	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-271	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
50844-271	Naproxen	Naproxen Sodium	L.N.K. International, Inc.	ANDA	Current
51824-071	CAREALL Naproxen	Naproxen Sodium	New World Imports, Inc.	ANDA	Current
51824-072	CAREALL Naproxen	Naproxen Sodium	New World Imports, Inc.	ANDA	Current
53185-004	Clear Choice Naproxen Sodium	Naproxen Sodium	Athlete's Needs Inc	ANDA	Current
53329-671	Naproxen Sodium	Naproxen Sodium	Medline Industries	ANDA	Current
53329-671	Naproxen Sodium	Naproxen Sodium	Medline Industries	ANDA	Current
53329-671	Naproxen Sodium	Naproxen Sodium	Medline Industries	ANDA	Current
53746-191	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-191	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-191	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-191	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-191	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-192	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-192	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-192	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-192	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-192	Naproxen Sodium (NSAID)	Naproxen Sodium	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53943-144	Naproxen	NAPROXEN SODIUM	DISCOUNT DRUG MART	ANDA	Current

Documents

Document	Title	Submission type	Submission no.	Date	Storage
23929	0	ORIG	1	2009-01-06	FDA source fallback