Details for New Drug Application (NDA): 212650
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The generic ingredient in RAMELTEON is ramelteon. There are three drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ramelteon profile page.
Pharmacology for NDA: 212650
Mechanism of Action | Melatonin Receptor Agonists |
Suppliers and Packaging for NDA: 212650
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RAMELTEON | ramelteon | TABLET;ORAL | 212650 | ANDA | TruPharma, LLC | 52817-235 | 52817-235-10 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52817-235-10) |
RAMELTEON | ramelteon | TABLET;ORAL | 212650 | ANDA | TruPharma, LLC | 52817-235 | 52817-235-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52817-235-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
Approval Date: | Apr 10, 2020 | TE: | AB | RLD: | No |
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