Details for New Drug Application (NDA): 211654
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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 211654
Tradename: | TASIMELTEON |
Applicant: | Msn |
Ingredient: | tasimelteon |
Patents: | 0 |
Pharmacology for NDA: 211654
Mechanism of Action | Melatonin Receptor Agonists |
Suppliers and Packaging for NDA: 211654
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TASIMELTEON | tasimelteon | CAPSULE;ORAL | 211654 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2548 | 69238-2548-3 | 30 CAPSULE in 1 BOTTLE (69238-2548-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
Approval Date: | Jan 12, 2023 | TE: | AB | RLD: | No |
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