Application 202413

Type: ANDA
Sponsor: SHANDONG XINHUA

Related Records

Company: SHANDONG XINHUA

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	No
004	IBUPROFEN	IBUPROFEN	TABLET;ORAL	300MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-008	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-009	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-010	ibuprofen	ibuprofen	AiPing Pharmaceutical Inc.	ANDA	Current
50090-4228	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-4230	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
51293-843	ibuprofen	ibuprofen	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-843	ibuprofen	ibuprofen	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-844	ibuprofen	ibuprofen	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-844	ibuprofen	ibuprofen	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-845	ibuprofen	ibuprofen	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-845	ibuprofen	ibuprofen	ECI PHARMACEUTICALS LLC	ANDA	Current
55700-633	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-633	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-634	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-634	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
58657-680	Ibuprofen	Ibuprofen	Method Pharmaceuticals, LLC	ANDA	Current
58657-680	Ibuprofen	Ibuprofen	Method Pharmaceuticals, LLC	ANDA	Current
58657-681	Ibuprofen	Ibuprofen	Method Pharmaceuticals, LLC	ANDA	Current
58657-681	Ibuprofen	Ibuprofen	Method Pharmaceuticals, LLC	ANDA	Current
58657-682	Ibuprofen	Ibuprofen	Method Pharmaceuticals, LLC	ANDA	Current
58657-682	Ibuprofen	Ibuprofen	Method Pharmaceuticals, LLC	ANDA	Current
62135-400	Ibuprofen	Ibuprofen	Chartwell RX, LLC	ANDA	Current
62135-400	Ibuprofen	Ibuprofen	Chartwell RX, LLC	ANDA	Current
62135-401	Ibuprofen	Ibuprofen	Chartwell RX, LLC	ANDA	Current
62135-401	Ibuprofen	Ibuprofen	Chartwell RX, LLC	ANDA	Current
62135-402	Ibuprofen	Ibuprofen	Chartwell RX, LLC	ANDA	Current
62135-402	Ibuprofen	Ibuprofen	Chartwell RX, LLC	ANDA	Current
67296-1573	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
67296-1573	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
67296-1633	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
67296-1633	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
67296-1634	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
67296-1634	Ibuprofen	Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
68788-8182	ibuprofen	ibuprofen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8183	ibuprofen	ibuprofen	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2902	ibuprofen	ibuprofen	REMEDYREPACK INC.	ANDA	Current
70518-2902	ibuprofen	ibuprofen	REMEDYREPACK INC.	ANDA	Current
70518-3016	ibuprofen	ibuprofen	REMEDYREPACK INC.	ANDA	Current
71335-1177	Ibuprofen	Ibuprofen	Bryant Ranch Prepack	ANDA	Current
71610-456	ibuprofen	ibuprofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71862-003	Ibuprofen	Ibuprofen	Landmark Supply Inc.	ANDA	Current
71862-003	Ibuprofen	Ibuprofen	Landmark Supply Inc.	ANDA	Current
71862-007	Ibuprofen	Ibuprofen	Landmark Supply Inc.	ANDA	Current
71862-007	Ibuprofen	Ibuprofen	Landmark Supply Inc.	ANDA	Current

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