Application 065398

Type: ANDA
Sponsor: LUPIN LTD

Related Records

Company: LUPIN LTD

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZITHROMYCIN	AZITHROMYCIN	TABLET;ORAL	EQ 250MG BASE	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6708	azithromycin monohydrate	azithromycin monohydrate	Major Pharmaceuticals	ANDA	Current
0904-6708	azithromycin monohydrate	azithromycin monohydrate	Major Pharmaceuticals	ANDA	Current
0904-6708	azithromycin monohydrate	azithromycin monohydrate	Major Pharmaceuticals	ANDA	Current
43063-728	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-728	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-728	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-728	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-728	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-728	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-728	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
53217-327	azithromycin monohydrate	azithromycin monohydrate	Aidarex Pharmaceuticals LLC	ANDA	Current
55154-8094	azithromycin monohydrate	azithromycin monohydrate	Cardinal Health 107, LLC	ANDA	Current
55154-8094	azithromycin monohydrate	azithromycin monohydrate	Cardinal Health 107, LLC	ANDA	Current
55154-8094	azithromycin monohydrate	azithromycin monohydrate	Cardinal Health	ANDA	Current
55700-432	azithromycin monohydrate	azithromycin monohydrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
57297-160	azithromycin monohydrate	azithromycin monohydrate	LUPIN LIMITED	ANDA	Current
60687-282	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
60687-282	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
60687-282	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
60687-282	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
60687-282	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
61919-170	AZITHROMYCIN MONOHYDRATE	AZITHROMYCIN MONOHYDRATE	Direct_Rx	ANDA	Current
68071-3136	azithromycin monohydrate	azithromycin monohydrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3136	azithromycin monohydrate	azithromycin monohydrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4214	azithromycin monohydrate	azithromycin monohydrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4230	azithromycin monohydrate	azithromycin monohydrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68180-160	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-160	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-160	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-160	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-160	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-861	azithromycin dihydrate	azithromycin dihydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68788-7654	azithromycin monohydrate	azithromycin monohydrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7654	azithromycin monohydrate	azithromycin monohydrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
69677-129	Azithromycin Monohydrate	Azithromycin Monohydrate	MAS MANAGEMENT GROUP, INC.	ANDA	Current
70518-0736	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0736	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0736	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0736	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0803	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0803	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0803	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0803	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0803	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
71205-119	azithromycin monohydrate	azithromycin monohydrate	Proficient Rx LP	ANDA	Current
71205-119	azithromycin monohydrate	azithromycin monohydrate	Proficient Rx LP	ANDA	Current
71205-119	azithromycin monohydrate	azithromycin monohydrate	Proficient Rx LP	ANDA	Current
71205-427	azithromycin monohydrate	azithromycin monohydrate	Proficient Rx LP	ANDA	Current
71205-427	azithromycin monohydrate	azithromycin monohydrate	Proficient Rx LP	ANDA	Current