Details for New Drug Application (NDA): 211601
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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 211601
Tradename: | TASIMELTEON |
Applicant: | Teva Pharms Usa Inc |
Ingredient: | tasimelteon |
Patents: | 0 |
Pharmacology for NDA: 211601
Mechanism of Action | Melatonin Receptor Agonists |
Suppliers and Packaging for NDA: 211601
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TASIMELTEON | tasimelteon | CAPSULE;ORAL | 211601 | ANDA | Teva Pharmaceuticals, Inc. | 0480-4490 | 0480-4490-56 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-4490-56) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
Approval Date: | Dec 12, 2022 | TE: | AB | RLD: | No |
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