Details for New Drug Application (NDA): 206153
NDA 206153 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 fifteen 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. Seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.
Summary for 206153
| Tradename: | RASAGILINE MESYLATE |
| Applicant: | Regcon Holdings |
| Ingredient: | rasagiline mesylate |
| Patents: | 0 |
Pharmacology for NDA: 206153
| Mechanism of Action | Monoamine Oxidase Inhibitors |
Suppliers and Packaging for NDA: 206153
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RASAGILINE MESYLATE | rasagiline mesylate | TABLET;ORAL | 206153 | ANDA | Florida Pharmaceutical Products, LLC | 71921-407 | 71921-407-33 | 30 TABLET in 1 BOTTLE (71921-407-33) |
| RASAGILINE MESYLATE | rasagiline mesylate | TABLET;ORAL | 206153 | ANDA | Florida Pharmaceutical Products, LLC | 71921-408 | 71921-408-33 | 30 TABLET in 1 BOTTLE (71921-408-33) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Oct 4, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Oct 4, 2019 | TE: | AB | RLD: | No | ||||
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