Details for New Drug Application (NDA): 201889
NDA 201889 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 201889
| Tradename: | RASAGILINE MESYLATE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | rasagiline mesylate |
| Patents: | 0 |
Pharmacology for NDA: 201889
| Mechanism of Action | Monoamine Oxidase Inhibitors |
Suppliers and Packaging for NDA: 201889
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RASAGILINE MESYLATE | rasagiline mesylate | TABLET;ORAL | 201889 | ANDA | NorthStar RxLLC | 16714-770 | 16714-770-01 | 30 TABLET in 1 BOTTLE (16714-770-01) |
| RASAGILINE MESYLATE | rasagiline mesylate | TABLET;ORAL | 201889 | ANDA | NorthStar RxLLC | 16714-771 | 16714-771-01 | 30 TABLET in 1 BOTTLE (16714-771-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Oct 30, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Oct 30, 2017 | TE: | AB | RLD: | No | ||||
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