Details for New Drug Application (NDA): 021641
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NDA 021641 describes AZILECT, which is a drug marketed by Teva and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AZILECT profile page.
The generic ingredient in AZILECT is rasagiline mesylate. There are eighteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.
The generic ingredient in AZILECT is rasagiline mesylate. There are eighteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.
Summary for 021641
| Tradename: | AZILECT |
| Applicant: | Teva |
| Ingredient: | rasagiline mesylate |
| Patents: | 2 |
Pharmacology for NDA: 021641
| Mechanism of Action | Monoamine Oxidase Inhibitors |
Suppliers and Packaging for NDA: 021641
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZILECT | rasagiline mesylate | TABLET;ORAL | 021641 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-3060 | 0093-3060-56 | 30 TABLET in 1 BOTTLE (0093-3060-56) |
| AZILECT | rasagiline mesylate | TABLET;ORAL | 021641 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-3061 | 0093-3061-56 | 30 TABLET in 1 BOTTLE (0093-3061-56) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | May 16, 2006 | TE: | AB | RLD: | Yes | ||||
| Patent: | 7,572,834 | Patent Expiration: | Dec 5, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 7,815,942 | Patent Expiration: | Aug 27, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PARKINSON'S DISEASE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | May 16, 2006 | TE: | AB | RLD: | Yes | ||||
| Patent: | 7,572,834 | Patent Expiration: | Dec 5, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 021641
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-002 | May 16, 2006 | 5,786,390 | ⤷ Subscribe |
| Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-002 | May 16, 2006 | 5,453,446 | ⤷ Subscribe |
| Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-001 | May 16, 2006 | 5,786,390 | ⤷ Subscribe |
| Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-001 | May 16, 2006 | 5,387,612 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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