Details for New Drug Application (NDA): 021641
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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: | ⤷ Sign Up | Patent Expiration: | Dec 5, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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 | 021641-001 | May 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-001 | May 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-002 | May 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641-002 | May 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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