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Last Updated: March 19, 2024

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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021259
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:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Apr 3, 2001TE:AB2RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Jun 19, 2003TE:AB2RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 27, 2003TE:AB2RLD:Yes

Expired US Patents for NDA 021259

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

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