Details for New Drug Application (NDA): 213815
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The generic ingredient in RAMELTEON is ramelteon. There are three drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ramelteon profile page.
Summary for 213815
Tradename: | RAMELTEON |
Applicant: | Upsher Smith Labs |
Ingredient: | ramelteon |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213815
Mechanism of Action | Melatonin Receptor Agonists |
Suppliers and Packaging for NDA: 213815
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RAMELTEON | ramelteon | TABLET;ORAL | 213815 | ANDA | Upsher-Smith Laboratories, LLC | 0832-1250 | 0832-1250-11 | 100 TABLET, FILM COATED in 1 BOTTLE (0832-1250-11) |
RAMELTEON | ramelteon | TABLET;ORAL | 213815 | ANDA | Upsher-Smith Laboratories, LLC | 0832-1250 | 0832-1250-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0832-1250-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
Approval Date: | Oct 26, 2020 | TE: | AB | RLD: | No |
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