Details for New Drug Application (NDA): 207004
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NDA 207004 describes RASAGILINE MESYLATE, which is a drug marketed by Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Usa, Chartwell Rx, Indoco, Macleods Pharms Ltd, Micro Labs, Orbion Pharms, Ryan Labs, Skg Pharma, and Watson Labs Inc, and is included in eleven NDAs. It is available from nine suppliers. Additional details are available on the RASAGILINE MESYLATE profile page.
The generic ingredient in RASAGILINE MESYLATE 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 RASAGILINE MESYLATE 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 207004
| Tradename: | RASAGILINE MESYLATE |
| Applicant: | Micro Labs |
| Ingredient: | rasagiline mesylate |
| Patents: | 0 |
Pharmacology for NDA: 207004
| Mechanism of Action | Monoamine Oxidase Inhibitors |
Suppliers and Packaging for NDA: 207004
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RASAGILINE MESYLATE | rasagiline mesylate | TABLET;ORAL | 207004 | ANDA | Micro Labs Limited | 42571-220 | 42571-220-05 | 500 TABLET in 1 BOTTLE (42571-220-05) |
| RASAGILINE MESYLATE | rasagiline mesylate | TABLET;ORAL | 207004 | ANDA | Micro Labs Limited | 42571-220 | 42571-220-10 | 1000 TABLET in 1 BOTTLE (42571-220-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Mar 29, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Mar 29, 2019 | TE: | AB | RLD: | No | ||||
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