Application 205081

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No
002	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
004	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	100MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-091	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-091	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-091	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-091	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-091	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-092	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-092	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-092	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-092	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-092	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-093	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-093	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-093	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-093	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-093	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-094	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-094	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-094	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-094	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-094	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current

Application 205081

Related Records#

Application Products#

NDC Listings For This Application#