Details for New Drug Application (NDA): 201892
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NDA 201892 describes RASAGILINE MESYLATE, which is a drug marketed by Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Usa, Carnegie, Chartwell Rx, Macleods Pharms, Micro Labs, Orbion Pharms, Regcon Holdings, Rising, Torrent, and Watson Labs Inc, and is included in twelve NDAs. It is available from fourteen suppliers. Additional details are available on the RASAGILINE MESYLATE profile page.
The generic ingredient in RASAGILINE MESYLATE is rasagiline mesylate. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.
The generic ingredient in RASAGILINE MESYLATE is rasagiline mesylate. There is one drug master file entry for this compound. Sixteen 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 |
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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