FDA Approved Products

Application #	Type	Sponsor	Product #	Drug Name	Form	Strength	Active Ingredient	Approval Date	Marketing Status	Reference Standard
022556	NDA	AYTU	001	KARBINAL ER	SUSPENSION, EXTENDED RELEASE;ORAL	4MG/5ML	CARBINOXAMINE MALEATE	2013-03-28	Prescription	Yes
204736	NDA	AYTU	001	ACIPHEX SPRINKLE	CAPSULE, DELAYED RELEASE;ORAL	5MG	RABEPRAZOLE SODIUM	2013-03-26	Discontinued	No
204736	NDA	AYTU	002	ACIPHEX SPRINKLE	CAPSULE, DELAYED RELEASE;ORAL	10MG	RABEPRAZOLE SODIUM	2013-03-26	Discontinued	No
022196	NDA	AYTU	001	ZOLPIMIST	SPRAY, METERED;ORAL	5MG/SPRAY	ZOLPIDEM TARTRATE	2008-12-19	Discontinued	No
021259	NDA	AYTU BIOPHARMA	001	METADATE CD	CAPSULE, EXTENDED RELEASE;ORAL	20MG	METHYLPHENIDATE HYDROCHLORIDE	2001-04-03	Prescription	No
			002	METADATE CD	CAPSULE, EXTENDED RELEASE;ORAL	30MG	METHYLPHENIDATE HYDROCHLORIDE	2001-04-03	Prescription	No
			003	METADATE CD	CAPSULE, EXTENDED RELEASE;ORAL	10MG	METHYLPHENIDATE HYDROCHLORIDE	2001-04-03	Prescription	No
			004	METADATE CD	CAPSULE, EXTENDED RELEASE;ORAL	40MG	METHYLPHENIDATE HYDROCHLORIDE	2001-04-03	Prescription	No
			005	METADATE CD	CAPSULE, EXTENDED RELEASE;ORAL	50MG	METHYLPHENIDATE HYDROCHLORIDE	2001-04-03	Prescription	No
			006	METADATE CD	CAPSULE, EXTENDED RELEASE;ORAL	60MG	METHYLPHENIDATE HYDROCHLORIDE	2001-04-03	Prescription	Yes