Details for New Drug Application (NDA): 218163
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NDA 218163 describes RASAGILINE MESYLATE, which is a drug marketed by Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Usa, Carnegie, Chartwell Rx, Indoco, Macleods Pharms Ltd, Micro Labs, Orbion Pharms, 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 218163
| Tradename: | RASAGILINE MESYLATE |
| Applicant: | Skg Pharma |
| Ingredient: | rasagiline mesylate |
| Patents: | 0 |
Pharmacology for NDA: 218163
| Mechanism of Action | Monoamine Oxidase Inhibitors |
Suppliers and Packaging for NDA: 218163
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RASAGILINE MESYLATE | rasagiline mesylate | TABLET;ORAL | 218163 | ANDA | SKG Pharma Inc. | 83085-007 | 83085-007-10 | 1000 TABLET in 1 BOTTLE (83085-007-10) |
| RASAGILINE MESYLATE | rasagiline mesylate | TABLET;ORAL | 218163 | ANDA | SKG Pharma Inc. | 83085-007 | 83085-007-30 | 30 TABLET in 1 BOTTLE (83085-007-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Apr 9, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Apr 9, 2024 | TE: | AB | RLD: | No | ||||
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