Application 203638

Type: ANDA
Sponsor: AMNEAL PHARMS

Related Records

Company: AMNEAL PHARMS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	15MG	No	No
004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No
005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6966	Oxycodone Hydrochloride	Oxycodone	Major Pharmaceuticals	ANDA	Current
0904-6966	Oxycodone Hydrochloride	Oxycodone	Major Pharmaceuticals	ANDA	Current
0904-7180	Oxycodone Hydrochloride	Oxycodone	Major Pharmaceuticals	ANDA	Current
61919-671	OXYCODONE HCL	OXYCODONE HCL	DIRECT RX	ANDA	Current
61919-671	OXYCODONE HCL	OXYCODONE HCL	DIRECT RX	ANDA	Current
61919-820	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-820	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-820	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-821	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-821	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
65162-047	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-047	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-047	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-047	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-047	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-048	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-048	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-048	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-048	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-048	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-049	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-049	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-049	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-049	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-049	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-050	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-050	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-050	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-050	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-050	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-051	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-051	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-051	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-051	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-051	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
68071-5055	Oxycodone Hydrochloride	Oxycodone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5055	Oxycodone Hydrochloride	Oxycodone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68094-005	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Precision Dose, Inc.	ANDA	Current
68094-005	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Precision Dose, Inc.	ANDA	Current
68094-005	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Precision Dose, Inc.	ANDA	Current
68094-005	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Precision Dose, Inc.	ANDA	Current
71335-0677	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-0677	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-0677	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-0981	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-0981	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-0981	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-1023	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-1023	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-1023	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-1080	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-1080	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-1101	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current

Documents

Document	Submission type	Date
76337	ORIG	2023-11-03