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-five suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
The generic ingredient in METADATE CD is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-five 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
| 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 | 6,344,215 | ⤷ Get Started Free |
| Aytu Biopharma | METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021259-004 | Feb 19, 2006 | 6,344,215 | ⤷ Get Started Free |
| Aytu Biopharma | METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021259-002 | Jun 19, 2003 | 6,344,215 | ⤷ Get Started Free |
| Aytu Biopharma | METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021259-003 | May 27, 2003 | 6,344,215 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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