Application 065308

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Related Records

Company: AUROBINDO PHARMA LTD

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFUROXIME AXETIL	CEFUROXIME AXETIL	TABLET;ORAL	EQ 125MG BASE	No	No
002	CEFUROXIME AXETIL	CEFUROXIME AXETIL	TABLET;ORAL	EQ 250MG BASE	No	No
003	CEFUROXIME AXETIL	CEFUROXIME AXETIL	TABLET;ORAL	EQ 500MG BASE	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-400	Cefuroxime Axetil	Cefuroxime Axetil	NorthStar Rx LLC	ANDA	Current
16714-400	Cefuroxime Axetil	Cefuroxime Axetil	NorthStar Rx LLC	ANDA	Current
16714-400	Cefuroxime Axetil	Cefuroxime Axetil	NorthStar Rx LLC	ANDA	Current
16714-400	Cefuroxime Axetil	Cefuroxime Axetil	NorthStar Rx LLC	ANDA	Current
16714-401	Cefuroxime Axetil	Cefuroxime Axetil	NorthStar Rx LLC	ANDA	Current
16714-401	Cefuroxime Axetil	Cefuroxime Axetil	NorthStar Rx LLC	ANDA	Current
16714-401	Cefuroxime Axetil	Cefuroxime Axetil	NorthStar Rx LLC	ANDA	Current
16714-401	Cefuroxime Axetil	Cefuroxime Axetil	NorthStar Rx LLC	ANDA	Current
21695-150	Cefuroxime axetil	Cefuroxime axetil	Rebel Distributors Corp	ANDA	Current
21695-370	Cefuroxime axetil	Cefuroxime axetil	Rebel Distributors Corp	ANDA	Current
43063-623	Cefuroxime Axetil	Cefuroxime Axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-623	Cefuroxime Axetil	Cefuroxime Axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-623	Cefuroxime Axetil	Cefuroxime Axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-623	Cefuroxime Axetil	Cefuroxime Axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-623	Cefuroxime Axetil	Cefuroxime Axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-0781	Cefuroxime Axetil	Cefuroxime Axetil	A-S Medication Solutions	ANDA	Current
50090-0781	Cefuroxime Axetil	Cefuroxime Axetil	A-S Medication Solutions	ANDA	Current
50090-4153	Cefuroxime Axetil	Cefuroxime Axetil	A-S Medication Solutions	ANDA	Current
52343-062	Cefuroxime Axetil	Cefuroxime Axetil	LUCID PHARMA LLC	ANDA	Current
52343-063	Cefuroxime Axetil	Cefuroxime Axetil	LUCID PHARMA LLC	ANDA	Current
52959-939	Cefuroxime Axetil	Cefuroxime Axetil	H.J. Harkins Company, Inc.	ANDA	Current
55700-436	Cefuroxime Axetil	Cefuroxime Axetil	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-436	Cefuroxime Axetil	Cefuroxime Axetil	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-436	Cefuroxime Axetil	Cefuroxime Axetil	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
57237-058	Cefuroxime Axetil	Cefuroxime Axetil	Rising Health, LLC	ANDA	Current
57237-058	Cefuroxime Axetil	Cefuroxime Axetil	Rising Health, LLC	ANDA	Current
57237-058	Cefuroxime Axetil	Cefuroxime Axetil	Rising Health, LLC	ANDA	Current
57237-058	Cefuroxime Axetil	Cefuroxime Axetil	Rising Health, LLC	ANDA	Current
57237-059	Cefuroxime Axetil	Cefuroxime Axetil	Rising Health, LLC	ANDA	Current
57237-059	Cefuroxime Axetil	Cefuroxime Axetil	Rising Health, LLC	ANDA	Current
57237-059	Cefuroxime Axetil	Cefuroxime Axetil	Rising Health, LLC	ANDA	Current
57237-059	Cefuroxime Axetil	Cefuroxime Axetil	Rising Health, LLC	ANDA	Current
61919-044	CEFUROXIME AXETIL	CEFUROXIME AXETIL	DIRECT RX	ANDA	Current
61919-044	CEFUROXIME AXETIL	CEFUROXIME AXETIL	DIRECT RX	ANDA	Current
61919-145	CEFUROXIME AXETIL	CEFUROXIME AXETIL	DIRECT RX	ANDA	Current
65862-698	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
65862-698	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
65862-698	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
65862-698	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
65862-698	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
65862-699	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
65862-699	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
65862-699	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
65862-699	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
65862-699	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
65862-700	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
65862-700	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
65862-700	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
65862-700	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
65862-700	Cefuroxime Axetil	Cefuroxime Axetil	Aurobindo Pharma Limited	ANDA	Current
68071-2879	Cefuroxime Axetil	Cefuroxime Axetil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2879	Cefuroxime Axetil	Cefuroxime Axetil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3000	Cefuroxime Axetil	Cefuroxime Axetil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3291	Cefuroxime Axetil	Cefuroxime Axetil	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-9914	Cefuroxime Axetil	Cefuroxime Axetil	Preferred Pharmaceuticali Inc.	ANDA	Current
70518-3215	Cefuroxime Axetil	Cefuroxime Axetil	REMEDYREPACK INC.	ANDA	Current
70934-088	Cefuroxime Axetil	Cefuroxime Axetil	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-088	Cefuroxime Axetil	Cefuroxime Axetil	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-088	Cefuroxime Axetil	Cefuroxime Axetil	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current