Application 206409

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE	TABLET;ORAL	EQ 20MG BASE	No	No
002	ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE	TABLET;ORAL	EQ 40MG BASE	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-922	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-922	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-922	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-922	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-923	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-923	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-923	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-923	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1107	Eletriptan hydrobromide	Eletriptan hydrobromide	Cadila Healthcare Limited	ANDA	Current
70771-1107	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Lifesciences Limited	ANDA	Current
70771-1107	Eletriptan hydrobromide	Eletriptan hydrobromide	Cadila Healthcare Limited	ANDA	Current
70771-1107	Eletriptan hydrobromide	Eletriptan hydrobromide	Cadila Healthcare Limited	ANDA	Current
70771-1108	Eletriptan hydrobromide	Eletriptan hydrobromide	Cadila Healthcare Limited	ANDA	Current
70771-1108	Eletriptan hydrobromide	Eletriptan hydrobromide	Zydus Lifesciences Limited	ANDA	Current
70771-1108	Eletriptan hydrobromide	Eletriptan hydrobromide	Cadila Healthcare Limited	ANDA	Current
70771-1108	Eletriptan hydrobromide	Eletriptan hydrobromide	Cadila Healthcare Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48782	ORIG	2017-06-20