Application 208829

Type: ANDA
Sponsor: AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	7.5MG	No	No
003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	15MG	No	No
005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4657	busPIRone HCl	buspirone hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4657	busPIRone HCl	buspirone hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4657	busPIRone HCl	buspirone hydrochloride	A-S Medication Solutions	ANDA	Current
55700-803	busPIRone HCl	buspirone hydrochloride	Quality Care Products, LLC	ANDA	Current
69238-1115	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1115	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1115	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1115	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1115	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1116	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1116	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1116	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1116	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1116	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1117	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1117	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1117	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1117	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1117	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1118	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1118	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1118	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1118	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1118	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1119	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1119	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1119	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1119	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1119	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
71335-1390	busPIRone HCl	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1390	busPIRone HCl	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current

Application 208829

Related Records#

Application Products#

NDC Listings For This Application#