Details for New Drug Application (NDA): 021259

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NDA 021259 describes METADATE CD, which is a drug marketed by Aytu Biopharma and is included in one NDA. It is available from two suppliers. Additional details are available on the METADATE CD profile page.

The generic ingredient in METADATE CD is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for 021259

Tradename:	METADATE CD
Applicant:	Aytu Biopharma
Ingredient:	methylphenidate hydrochloride
Patents:	0

Pharmacology for NDA: 021259

Physiological Effect	Central Nervous System Stimulation

Suppliers and Packaging for NDA: 021259

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259	NDA AUTHORIZED GENERIC	Lannett Company, Inc.	0527-4579	0527-4579-37	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4579-37)
METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259	NDA AUTHORIZED GENERIC	Lannett Company, Inc.	0527-4580	0527-4580-37	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4580-37)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	20MG
Approval Date:	Apr 3, 2001	TE:	AB2	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	30MG
Approval Date:	Jun 19, 2003	TE:	AB2	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	May 27, 2003	TE:	AB2	RLD:	Yes

Expired US Patents for NDA 021259

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-001	Apr 3, 2001	⤷ Sign Up	⤷ Sign Up
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-004	Feb 19, 2006	⤷ Sign Up	⤷ Sign Up
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-003	May 27, 2003	⤷ Sign Up	⤷ Sign Up
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-002	Jun 19, 2003	⤷ Sign Up	⤷ Sign Up
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