Details for New Drug Application (NDA): 211607
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NDA 211607 describes TASIMELTEON, which is a drug marketed by Apotex, MSN, and Teva Pharms Usa Inc, and is included in three NDAs. It is available from three suppliers. Additional details are available on the TASIMELTEON profile page.
The generic ingredient in TASIMELTEON is tasimelteon. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tasimelteon profile page.
The generic ingredient in TASIMELTEON is tasimelteon. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tasimelteon profile page.
Summary for 211607
| Tradename: | TASIMELTEON |
| Applicant: | Apotex |
| Ingredient: | tasimelteon |
| Patents: | 0 |
Pharmacology for NDA: 211607
| Mechanism of Action | Melatonin Receptor Agonists |
Suppliers and Packaging for NDA: 211607
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TASIMELTEON | tasimelteon | CAPSULE;ORAL | 211607 | ANDA | Apotex Corp. | 60505-4665 | 60505-4665-3 | 30 CAPSULE in 1 BOTTLE (60505-4665-3) |
| TASIMELTEON | tasimelteon | CAPSULE;ORAL | 211607 | ANDA | Apotex Corp. | 60505-4665 | 60505-4665-9 | 90 CAPSULE in 1 BOTTLE (60505-4665-9) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | Dec 20, 2022 | TE: | AB | RLD: | No | ||||
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