Application 208615

Type: ANDA
Sponsor: SCINOPHARM TAIWAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	INJECTABLE;SUBCUTANEOUS	2.5MG/0.5ML	No	No
002	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	INJECTABLE;SUBCUTANEOUS	5MG/0.4ML	No	No
003	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	INJECTABLE;SUBCUTANEOUS	7.5MG/0.6ML	No	No
004	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	INJECTABLE;SUBCUTANEOUS	10MG/0.8ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11797-154	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-154	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-154	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-155	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-155	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-155	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-156	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-156	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-156	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-157	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-157	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-157	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
70710-1514	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1514	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1514	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1514	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1515	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1515	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1515	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1515	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1516	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1516	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1516	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1516	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1517	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1517	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1517	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1517	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current

Application 208615

Related Records#

Application Products#

NDC Listings For This Application#