Details for New Drug Application (NDA): 201892
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The generic ingredient in RASAGILINE MESYLATE is rasagiline mesylate. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.
Summary for 201892
Tradename: | RASAGILINE MESYLATE |
Applicant: | Chartwell Rx |
Ingredient: | rasagiline mesylate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201892
Mechanism of Action | Monoamine Oxidase Inhibitors |
Suppliers and Packaging for NDA: 201892
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RASAGILINE MESYLATE | rasagiline mesylate | TABLET;ORAL | 201892 | ANDA | Chartwell RX, LLC | 62135-676 | 62135-676-30 | 30 TABLET in 1 BOTTLE (62135-676-30) |
RASAGILINE MESYLATE | rasagiline mesylate | TABLET;ORAL | 201892 | ANDA | Chartwell RX, LLC | 62135-677 | 62135-677-30 | 30 TABLET in 1 BOTTLE (62135-677-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE | ||||
Approval Date: | Jul 27, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
Approval Date: | Jul 27, 2018 | TE: | AB | RLD: | No |
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